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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 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 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.
Device Class : 2
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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).
Device Class : 1
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 614218634
Premarket Exempt : No
Prescription Use : Yes