Address:2001 KRAFT DR.,BLACKSBURG,VA,24060,US
Device Description : The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence ofE. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test.
Device Class : 2
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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).
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes