TECHLAB, INC.

Address:2001 KRAFT DR.,BLACKSBURG,VA,24060,US

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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

Product Code : KHW

Prescription Use : Yes

Device Count : 1

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

Product Code : MHI

Prescription Use : Yes

Device Count : 1

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

Product Code : MHJ

Prescription Use : Yes

Device Count : 1

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

Product Code : LLH

Prescription Use : Yes

Device Count : 1

Device Description : 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.

Device Class : 1

Duns Number: 614218634

Premarket Exempt : No

Product Code : LLH

Prescription Use : Yes

Device Count : 1

Device Description : The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. 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

Product Code : LLH

Prescription Use : Yes

Device Count : 1

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

Product Code : LLH

Prescription Use : Yes

Device Count : 1

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

Product Code : DEG

Prescription Use : Yes

Device Count : 1

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

Product Code : DEG

Prescription Use : Yes

Device Count : 1

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

Product Code : LLH

Prescription Use : Yes

Device Count : 1