Campylobacter Chek
Techlab, Inc.
TECHLAB, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1122855 | 1000123404 | TECHLAB, INC. | 1 | Y | 2026-01-01 | 2001 KRAFT DRIVE BLACKSBURG VA US 24060 |
| 3009935129 | 3009935129 | TECHLAB, INC. | 1 | Y | 2026-01-01 | 20 Corporate Drive Radford VA US 24141 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 169940 | 1822216200 | K994101 | E. HISTOLYTICA II | KHW | 1999-12-21 |
| 43088 | 1822216200 | K994101 | E. HISTOLYTICA II | KHW | 1999-12-21 |
| 169940 | 1884521047 | K951101 | LEUKO-TEST | DEG | 1995-04-24 |
| 43088 | 1884521047 | K951101 | LEUKO-TEST | DEG | 1995-04-24 |
| 43088 | 1617124928 | K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT | LLH | 1993-02-01 |
| 169940 | 1617124928 | K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT | LLH | 1993-02-01 |
| 169940 | 1503631641 | K181400 | H. PYLORI CHEK™ | LYR | 2018-08-21 |
| 43088 | 1503631641 | K181400 | H. PYLORI CHEK™ | LYR | 2018-08-21 |
| 169940 | 1372589682 | K181379 | H. PYLORI QUIK CHEK | LYR | 2018-08-21 |
| 43088 | 1372589682 | K181379 | H. PYLORI QUIK CHEK | LYR | 2018-08-21 |
| 169940 | 2045932782 | K173219 | CAMPYLOBACTER CHEK | LQP | 2018-01-22 |
| 43088 | 2045932782 | K173219 | CAMPYLOBACTER CHEK | LQP | 2018-01-22 |
| 43088 | 2011045058 | K173217 | CAMPYLOBACTER QUIK CHEK | LQP | 2018-01-22 |
| 169940 | 2011045058 | K173217 | CAMPYLOBACTER QUIK CHEK | LQP | 2018-01-22 |
| 43088 | 1002223883 | K171078 | TRI-COMBO PARASITE SCREEN | MHJ | 2017-07-10 |
| 169940 | 1002223883 | K171078 | TRI-COMBO PARASITE SCREEN | MHJ | 2017-07-10 |
| 169940 | 1579066675 | K170728 | E. HISTOLYTICA QUIK CHEK | KHW | 2017-06-07 |
| 43088 | 1579066675 | K170728 | E. HISTOLYTICA QUIK CHEK | KHW | 2017-06-07 |
| 43088 | 1882230085 | K121411 | SHIGA TOXIN CHEK | GMZ | 2012-10-02 |
| 169940 | 1882230085 | K121411 | SHIGA TOXIN CHEK | GMZ | 2012-10-02 |
| 43088 | 1968916248 | K121364 | SHIGA TOXIN QUIK CHEK | GMZ | 2012-10-02 |
| 169940 | 1968916248 | K121364 | SHIGA TOXIN QUIK CHEK | GMZ | 2012-10-02 |
| 169940 | 1002087701 | K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | MHI | 2011-08-18 |
| 43088 | 1002087701 | K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | MHI | 2011-08-18 |
| 43088 | 1054717685 | K082499 | C. DIFF QUIK CHEK COMPLETE | LLH | 2009-03-26 |
| 169940 | 1054717685 | K082499 | C. DIFF QUIK CHEK COMPLETE | LLH | 2009-03-26 |
| 43088 | 1852986670 | K071712 | LEUKO EZ VUE | DEG | 2007-12-04 |
| 169940 | 1852986670 | K071712 | LEUKO EZ VUE | DEG | 2007-12-04 |
| 169940 | 1033557297 | K071711 | ASCA-CHEK | NBT | 2007-11-07 |
| 43088 | 1033557297 | K071711 | ASCA-CHEK | NBT | 2007-11-07 |
| 43088 | 1623123506 | K053572 | C. DIFF QUIK CHEK | MCB | 2006-04-26 |
| 169940 | 1623123506 | K053572 | C. DIFF QUIK CHEK | MCB | 2006-04-26 |
| 43088 | 1806694917 | K052932 | CRYPTOSPORIDIUM II | MHJ | 2005-11-04 |
| 169940 | 1806694917 | K052932 | CRYPTOSPORIDIUM II | MHJ | 2005-11-04 |
| 43088 | 1350181721 | K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK | MHJ | 2005-11-17 |
| 169940 | 1350181721 | K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK | MHJ | 2005-11-17 |
| 43088 | 1154724035 | K050891 | TOX A/B QUICK CHEK | LLH | 2005-07-25 |
| 169940 | 1154724035 | K050891 | TOX A/B QUICK CHEK | LLH | 2005-07-25 |
| 43088 | 1147022708 | K042071 | IBD-SCAN | DEG | 2004-10-20 |
| 169940 | 1147022708 | K042071 | IBD-SCAN | DEG | 2004-10-20 |
| 43088 | 1140591935 | K033274 | GIARDIA II | MHI | 2003-11-04 |
| 169940 | 1140591935 | K033274 | GIARDIA II | MHI | 2003-11-04 |
| 169940 | 1904209872 | K030992 | C. DIFF CHEK - 60 | LLH | 2003-07-11 |
| 43088 | 1904209872 | K030992 | C. DIFF CHEK - 60 | LLH | 2003-07-11 |
| 43088 | 1219464043 | K030704 | IBD-QUIK CHEK | DEG | 2003-04-21 |
| 169940 | 1219464043 | K030704 | IBD-QUIK CHEK | DEG | 2003-04-21 |
| 43088 | 1328073993 | K011396 | IBD-CHEK | DEG | 2001-06-18 |
| 169940 | 1328073993 | K011396 | IBD-CHEK | DEG | 2001-06-18 |
| 43088 | 1244665150 | K003306 | C. DIFFICILE TOX A/B II | LLH | 2000-11-22 |
| 169940 | 1244665150 | K003306 | C. DIFFICILE TOX A/B II | LLH | 2000-11-22 |
| 43088 | 1264848837 | ||||
| 169940 | 1264848837 | ||||
| 43088 | 1513785088 | ||||
| 169940 | 1513785088 | ||||
| 43088 | 1835312618 | ||||
| 169940 | 1835312618 | ||||
| 43088 | 2022510556 | ||||
| 169940 | 2022510556 |
Product Codes Associated With Registrations#
PMN#
H. PYLORI QUIK CHEK
TECHLAB, Inc.
H. PYLORI CHEK™
TECHLAB, Inc.
CAMPYLOBACTER QUIK CHEK
Techlab, Inc.
CAMPYLOBACTER CHEK
Techlab, Inc.
TRI-COMBO PARASITE SCREEN
Techlab, Inc.
E. HISTOLYTICA QUIK CHEK
TECHLAB, Inc.
C. DIFF QUIK CHEK COMPLETE
TECHLAB, INC.
C. DIFF QUIK CHEK
TECHLAB, INC.
TECHLAB ASCA-CHEK
TECHLAB, INC.
GIARDIA/CRYPTOSPORIDIUM CHEK
TECHLAB, INC.
CRYPTOSPORIDIUM II
TECHLAB, INC.
TOX A/B QUICK CHEK
TECHLAB, INC.
IBD-SCAN
TECHLAB, INC.
GIARDIA II
TECHLAB, INC.
C. DIFF CHEK - 60
TECHLAB, INC.
C. DIFFICILE TOX A/B II
TECHLAB, INC.
IBD-QUIK CHEK
TECHLAB, INC.
IBD-CHEK
TECHLAB, INC.
C. DIFFICILE TOX A/B II
TECHLAB, INC.
E. HISTOLYTICA II
TECHLAB, INC.
CRYPTOSPORIDIUM TEST
TECHLAB, INC.
TOX A/B TEST
TECHLAB, INC.
GIARDIA CELISA
TECHLAB, INC.
E. HISTOLYTICA TEST
TECHLAB, INC.
CRYPTO/GIARDIA-CEL IF TEST
TECHLAB, INC.
CRYPTO-CEL IF TEST
TECHLAB, INC.
LEUKO-TEST
TECHLAB, INC.
ENTAMOEBA TEST
TECHLAB, INC.
CLOSTRIDIUM DIFFICILE TOX-B TEST
TECHLAB, INC.
FAST'N'FLAMMATORY KIT
TECHLAB, INC.
TECHLAB 1-HOUR TOX-A-TEST
TECHLAB, INC.
CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT
TECHLAB, INC.
CLOSTRIDIUM DIFFICILE TOX-A-TEST
TECHLAB, INC.
GUDID#
TRI-COMBO PARASITE SCREEN - 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.
2019-05-31
C. DIFF QUIK CHEK COMPLETE - 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.
2019-05-31
C. DIFFICILE TOX-B TEST - 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.
2020-01-24
LEUKO EZ VUE - 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.
2020-01-24
QuickVue TLI H. pylori Test - 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.
2019-05-30
C. DIFF CHEK - 60 - 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.
2019-04-12
CAMPYLOBACTER QUIK CHEK - 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.
2019-04-12
CRYPTOSPORIDIUM II - 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.
2016-08-23
H. PYLORI CHEK - 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.
2018-09-28
LACTOFERRIN EZ VUE - 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).
2019-05-31
QuickVue TLI Lactoferrin Test - The QuickVue TLI Lactoferrin 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).
2019-05-30
LACTOFERRIN EZ VUE - 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).
2019-05-29
LEUKO EZ VUE - 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.
2019-04-12
C. DIFFICILE TOX A/B II - 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.
2021-05-07
C. DIFF CHEK - 60 - 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.
2021-05-03
H. PYLORI CHEK - 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.
2021-03-12
C. DIFFICILE TOXIN ANTITOXIN KIT - 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.
2020-01-24
C. DIFFICILE TOX-B TEST - 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.
2020-01-24
QuickVue TLI H. pylori Stool Antigen Test - 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.
2019-09-26
SHIGA TOXIN QUIK CHEK - 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.
2019-08-06
SHIGA TOXIN CHEK - 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.
2019-08-06
CAMPYLOBACTER CHEK - 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.
2019-08-06
C. DIFFICILE TOX A/B II - 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.
2019-05-31
C. DIFF CHEK - 60 - 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.
2019-05-31
QuickVue TLI Campylobacter Test - 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.
2019-05-30
LACTOFERRIN CHEK - 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.
2019-05-29
CAMPYLOBACTER CHEK - 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.
2019-05-29
CAMPYLOBACTER QUIK CHEK - 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.
2019-05-29
LACTOFERRIN SCAN - 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).
2019-04-12
C. DIFF CHEK - 60 - 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.
2019-04-12
C. DIFFICILE TOX A/B II - 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.
2019-04-12
LACTOFERRIN CHEK - 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.
2019-04-12
LACTOFERRIN SCAN - 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).
2019-04-12
C. DIFFICILE TOX A/B II - 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.
2018-10-31
C. DIFF CHEK - 60 - 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.
2018-10-31
C. DIFF QUIK CHEK - 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.
2018-09-28
C. DIFFICILE TOX A/B II - 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.
2018-09-28
H. PYLORI QUIK CHEK - 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.
2018-09-28
H. PYLORI CHEK - 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.
2018-09-28
H. PYLORI QUIK CHEK - 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.
2018-09-28