Other products from "TECHLAB, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857031002646 T5015XB The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFFICILE TOX A/B II
2 00857031002257 T5033 The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium dif The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 TOX A/B QUIK CHEK
3 00857031002431 30397B The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFFICILE TOX A/B II
4 00857031002424 T5015B The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFFICILE TOX A/B II
5 00857031002219 T5015 The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFFICILE TOX A/B II
6 00857031002103 30397 The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFFICILE TOX A/B II
7 00857031002042 30394 The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium dif The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 TOX A/B QUIK CHEK
8 00857031002288 T5009 The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker for fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). DEG Lactoferrin, Antigen, Antiserum, Control 1 LACTOFERRIN SCAN
9 00857031002097 30351 The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker for fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). DEG Lactoferrin, Antigen, Antiserum, Control 1 LACTOFERRIN SCAN
10 00857031002417 T30696 The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitat The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coli (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history. GMZ Antigens, All Types, Escherichia Coli 1 SHIGA TOXIN CHEK
11 00857031002356 T5018 The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitativ The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). DEG Lactoferrin, Antigen, Antiserum, Control 1 LACTOFERRIN EZ VUE
12 00857031002295 PT5012 The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Gi The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. MHI Giardia Spp. 2 GIARDIA II
13 00857031002189 30353 The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitativ The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). DEG Lactoferrin, Antigen, Antiserum, Control 1 LACTOFERRIN EZ VUE
14 00857031002028 30405 The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Gi The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. MHI Giardia Spp. 2 GIARDIA II
15 00857031002264 T5003 The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue c The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFFICILE TOX-B TEST
16 00857031002639 T5051B The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. LYR Helicobacter Pylori 1 H. PYLORI CHEK
17 00857031002547 T5032 The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the sim The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis. KHW,MHI,MHJ Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.,Giardia Spp.,Cryptosporidium Spp. 2 TRI-COMBO PARASITE SCREEN
18 00857031002509 T5051 The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. LYR Helicobacter Pylori 1 H. PYLORI CHEK
19 00857031002486 T31096 The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detect The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. LQP Campylobacter Spp. 1 CAMPYLOBACTER CHEK
20 00857031002479 T31025 The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorben The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. LQP Campylobacter Spp. 1 CAMPYLOBACTER QUIK CHEK
21 00857031002462 T5052 The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detect The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. LQP Campylobacter Spp. 1 CAMPYLOBACTER CHEK
22 00857031002455 T5047 The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorben The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. LQP Campylobacter Spp. 1 CAMPYLOBACTER QUIK CHEK
23 00857031002400 T30408 The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the sim The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis. MHJ,MHI,KHW Cryptosporidium Spp.,Giardia Spp.,Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. 2 TRI-COMBO PARASITE SCREEN
24 00857031002301 PT5014 The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detecti The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. MHJ Cryptosporidium Spp. 2 CRYPTOSPORIDIUM II
25 00857031002271 T5008 The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active irritable bowel syndrome (IBS), which is noninflammatory. DEG Lactoferrin, Antigen, Antiserum, Control 1 LACTOFERRIN CHEK
26 00857031002080 30352 The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active irritable bowel syndrome (IBS), which is noninflammatory. DEG Lactoferrin, Antigen, Antiserum, Control 1 LACTOFERRIN CHEK
27 00857031002073 30399U The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue c The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFFICILE TOX-B TEST
28 00857031002035 30406 The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detecti The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. MHJ Cryptosporidium Spp. 2 CRYPTOSPORIDIUM II
29 00857031002516 30925 The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. LYR Helicobacter Pylori 1 H. PYLORI QUIK CHEK
30 00857031002493 T5050 The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. LYR Helicobacter Pylori 1 H. PYLORI QUIK CHEK
31 00857031002240 T5031 The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitati The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections. MHJ Cryptosporidium Spp. 2 GIARDIA/CRYPTOSPORIDIUM CHEK
32 00857031002202 T30409 The TECHLAB­ E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoass The TECHLAB­ E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of adhesin from Entamoeba histolytica in a single use cassette. It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history. FOR IN VITRO DIAGNOSTIC USE KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. 2 E. HISTOLYTICA QUIK CHEK
33 00857031002196 T30625 The SHIGA TOXIN QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the s The SHIGA TOXIN QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC). It may be used with fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history. GMZ Antigens, All Types, Escherichia Coli 1 SHIGA TOXIN QUIK CHEK
34 00857031002127 30401 The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitati The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections. MHJ Cryptosporidium Spp. 2 GIARDIA/CRYPTOSPORIDIUM CHEK
35 00857031002561 20343 The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the q The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. LYR Helicobacter Pylori 1 QuickVue TLI H. pylori Test
36 00857031002554 T5038 The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoa The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detectsC. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF QUIK CHEK COMPLETE
37 00857031002387 30550C The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF QUIK CHEK COMPLETE
38 00857031002370 30525C The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF QUIK CHEK COMPLETE
39 00857031002158 T30550C The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoa The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF QUIK CHEK COMPLETE
40 00857031002059 T30525C The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoa The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF QUIK CHEK COMPLETE
41 00857031002660 TL5025 The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimensfrom persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests thatdetect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction withpatient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF CHEK - 60
42 00857031002578 20344 The QuickVue TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorb The QuickVue TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The QuickVue TLI Campylobacter Test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. LQP Campylobacter Spp. 1 QuickVue TLI Campylobacter Test
43 00857031002530 T5019 The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative dete The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. DEG Lactoferrin, Antigen, Antiserum, Control 1 LEUKO EZ VUE
44 00857031002448 30392B The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimensfrom persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests thatdetect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction withpatient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF CHEK - 60
45 00857031002233 T5025B The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimensfrom persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests thatdetect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction withpatient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF CHEK - 60
46 00857031002325 T5016 The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the quali The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn’s disease in combination with clinical and other laboratory findings.FOR IN VITRO DIAGNOSTIC USE. NBT Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae) 2 ASCA-CHEK
47 00857031002226 T5025 The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimensfrom persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests thatdetect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction withpatient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF CHEK - 60
48 00857031002172 T30355 The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative dete The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. DEG Lactoferrin, Antigen, Antiserum, Control 1 LEUKO EZ VUE
49 00857031002141 30390 The C. DIFF QUIK CHEK test is a rapid membrane enzyme immunoassay for use as a The C. DIFF QUIK CHEK test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. MCB Antigen, C. Difficile 1 C. DIFF QUIK CHEK
50 00857031002110 30392 The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimensfrom persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests thatdetect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction withpatient history. LLH Reagents, Clostridium Difficile Toxin 1 C. DIFF CHEK - 60
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1 05391516748834 1206651 1206651 Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative Trinity Biotech MARDX DIAGNOSTICS, INC.
2 05391516748827 1206650 1206650 Uni-Gold™ H. pylori Antigen, 20 Tests Trinity Biotech MARDX DIAGNOSTICS, INC.
3 05391516747738 41-9002 41-9002 Marsorb G, 10.0 mL Trinity Biotech MARDX DIAGNOSTICS, INC.
4 05391516747721 40-1013 40-1013 10x Wash Solution, 100 mL Trinity Biotech MARDX DIAGNOSTICS, INC.
5 05391516747714 40-1006 40-1006 EIA Color Developer, 13.0 mL Trinity Biotech MARDX DIAGNOSTICS, INC.
6 05391516747516 2346401 2346401 Captia H. pylori IgG Trinity Biotech CLARK LABORATORIES, INC.
7 05391516743686 2326430 2326430 Captia™ H. pylori IgA Trinity Biotech CLARK LABORATORIES, INC.
8 05391516743679 2346400 2346400 Captia™ H. pylori IgG Trinity Biotech CLARK LABORATORIES, INC.
9 03573026509231 30192-01 VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® instruments , for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA). VIDAS® H. pylori IgG BIOMERIEUX SA
10 00893029002571 GIS-62-2ML GIS-62-2ML Urease Glycerol Solution Urease GI SUPPLY, INC.
11 00893029002519 GIS-22 GIS-22 HpFast detects the urease enzyme for the presumptive identification of Helicobac HpFast detects the urease enzyme for the presumptive identification of Helicobacter pylori gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. HpFast GI SUPPLY, INC.
12 00893029002502 GIS-64 GIS-64 HpOne detects the urease enzyme for the presumptive identification of Helicobact HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. HpOne GI SUPPLY, INC.
13 00857031002639 T5051B The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. H. PYLORI CHEK TECHLAB, INC.
14 00857031002622 20343 The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoa The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. QuickVue TLI H. pylori Stool Antigen Test TECHLAB, INC.
15 00857031002561 20343 The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the q The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. QuickVue TLI H. pylori Test TECHLAB, INC.
16 00857031002523 30996 The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. H. PYLORI CHEK TECHLAB, INC.
17 00857031002516 30925 The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. H. PYLORI QUIK CHEK TECHLAB, INC.
18 00857031002509 T5051 The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. H. PYLORI CHEK TECHLAB, INC.
19 00857031002493 T5050 The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. H. PYLORI QUIK CHEK TECHLAB, INC.
20 00855574005414 HP20 H. Pylori, Immunochromatographic Poly stat POLYMEDCO, INC.
21 00850487007654 H. pylori A Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) SeraQuest QUEST INTERNATIONAL, INC.
22 00850487007647 H. pylori A Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) ReQuest QUEST INTERNATIONAL, INC.
23 00850487007531 H.pylori G 01550Q-1 Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SeraQuest QUEST INTERNATIONAL, INC.
24 00850487007159 H.pylori G 01550Q-1 Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) ReQuest QUEST INTERNATIONAL, INC.
25 00840733102271 760130 760130 Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluoresce Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. Curian HpSA MERIDIAN BIOSCIENCE, INC.
26 00840733101779 710030 710030 The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative pro The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. The ImmunoCard H. pylori assay may be performed in clinical laboratories and physician's offices. ImmunoCard H. pylori MERIDIAN BIOSCIENCE, INC.
27 00840733101731 606096 606096 Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative de Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative detection of IgG antibodies to Helicobacter pylori in human serum and plasma. Test results are intended to aid in the diagnosis of H. pylori infection. PREMIER H. pylori MERIDIAN BIOSCIENCE, INC.
28 00840733101670 601396 601396 The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitati The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. PREMIER Platinum HpSA PLUS MERIDIAN BIOSCIENCE, INC.
29 00840733101427 610190 610190 Curian is an Immunoassay Analyzer designed to automate incubation, results inter Curian is an Immunoassay Analyzer designed to automate incubation, results interpretation and results reporting of immunoassay diagnostic products. Curian is intended for use with Curian fluorescent immunoassay products. Curian-compatible Meridian Bioscience products are described in individual immunoassay package inserts. Curian Analyzer MERIDIAN BIOSCIENCE, INC.
30 00840733101380 750220 750220 The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the dete The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. ImmunoCard STAT! HpSA MERIDIAN BIOSCIENCE, INC.
31 00817273020037 300-331A 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit Diamedix DIAMEDIX CORPORATION
32 00816870022741 1475-300 1475-300A Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 96 Wells MONOBIND, INC.
33 00816870022734 1575-300 1575-300A Monobind AccuLite Anti-H. Pylori IgG CLIA Kit - 96 Wells MONOBIND, INC.
34 00816870022727 1675-300 1675-300A Monobind AccuLite Anti-H. Pylori IgA CLIA Kit - 96 Wells MONOBIND, INC.
35 00816870021102 1425-300 1425-300A Monobind AccuBind Anti-H. Pylori IgM ELISA Kit - 96 Wells MONOBIND, INC.
36 00816870021096 1525-300 1525-300A Monobind AccuBind Anti-H. Pylori IgG ELISA Kit - 96 Wells MONOBIND, INC.
37 00816870021089 1625-300 1625-300A Monobind AccuBind Anti-H. Pylori IgA ELISA Kit - 96 Wells MONOBIND, INC.
38 00742860100161 175 175 OSOM H Pylori 25 Test Kit SEKISUI DIAGNOSTICS, LLC
39 00722066000304 HPY-13C15 HPY-13C15 Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma. Rapid Response BTNX INC
40 00695684330200 33020 A rapid cassette test for the qualitative detection of Helicobabacter pylori in A rapid cassette test for the qualitative detection of Helicobabacter pylori in serum, plasma, or whole blood. AIMSTEP H. PYLORI GERMAINE LABORATORIES, INC
41 00657498000014 6300-020 6300-020 For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. RELY® H.Pylori STANBIO LABORATORY, L.P.
42 00630414989907 10469596 LHPGCM H.Pylori - IMMULITE - CTL IMMULITE® Systems HPG CONTROL H.pylori IgG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
43 00630414964164 10381272 LKHPG1 Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
44 00630414961644 10381335 L2KHPG6 Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests IMMULITE® 2000 Systems HPG H.pylori IgG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
45 00630414961637 10381336 L2KHPG2 Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests IMMULITE® 2000 Systems HPG H.pylori IgG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
46 00630414960944 10385353 L1KIDW1 Infectious Disease Diluent - IMMULITE - CAL IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
47 00613647000519 4581465021 23900535 SURE-VUE H. PYLORI 30/PK Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C.
48 00612479202719 5007 TEST KIT, H PYLORI (10/KT) McKesson MCKESSON MEDICAL-SURGICAL INC.
49 00612479202702 5008 TEST KIT, H PYLORI (25/KT) McKesson MCKESSON MEDICAL-SURGICAL INC.
50 00350770927459 92745 60480 AVANOS* CLOTEST* Rapid Urease Test AVANOS AVANOS MEDICAL, INC.