FDA.reportPublic FDA data

TECHLAB, INC.

Matched from indexed company URL: Techlab, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11228551000123404TECHLAB, INC.1Y2026-01-012001 KRAFT DRIVE BLACKSBURG VA US 24060
30099351293009935129TECHLAB, INC.1Y2026-01-0120 Corporate Drive Radford VA US 24141

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1699401822216200K994101E. HISTOLYTICA IIKHW1999-12-21
430881822216200K994101E. HISTOLYTICA IIKHW1999-12-21
1699401884521047K951101LEUKO-TESTDEG1995-04-24
430881884521047K951101LEUKO-TESTDEG1995-04-24
1699401617124928K923463CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KITLLH1993-02-01
430881617124928K923463CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KITLLH1993-02-01
1699401503631641K181400H. PYLORI CHEK™LYR2018-08-21
430881503631641K181400H. PYLORI CHEK™LYR2018-08-21
1699401372589682K181379H. PYLORI QUIK CHEKLYR2018-08-21
430881372589682K181379H. PYLORI QUIK CHEKLYR2018-08-21
1699402045932782K173219CAMPYLOBACTER CHEKLQP2018-01-22
430882045932782K173219CAMPYLOBACTER CHEKLQP2018-01-22
1699402011045058K173217CAMPYLOBACTER QUIK CHEKLQP2018-01-22
430882011045058K173217CAMPYLOBACTER QUIK CHEKLQP2018-01-22
1699401002223883K171078TRI-COMBO PARASITE SCREENMHJ2017-07-10
430881002223883K171078TRI-COMBO PARASITE SCREENMHJ2017-07-10
1699401579066675K170728E. HISTOLYTICA QUIK CHEKKHW2017-06-07
430881579066675K170728E. HISTOLYTICA QUIK CHEKKHW2017-06-07
430881882230085K121411SHIGA TOXIN CHEKGMZ2012-10-02
1699401882230085K121411SHIGA TOXIN CHEKGMZ2012-10-02
430881968916248K121364SHIGA TOXIN QUIK CHEKGMZ2012-10-02
1699401968916248K121364SHIGA TOXIN QUIK CHEKGMZ2012-10-02
430881002087701K103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKMHI2011-08-18
1699401002087701K103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKMHI2011-08-18
430881054717685K082499C. DIFF QUIK CHEK COMPLETELLH2009-03-26
1699401054717685K082499C. DIFF QUIK CHEK COMPLETELLH2009-03-26
1699401852986670K071712LEUKO EZ VUEDEG2007-12-04
430881852986670K071712LEUKO EZ VUEDEG2007-12-04
430881033557297K071711ASCA-CHEKNBT2007-11-07
1699401033557297K071711ASCA-CHEKNBT2007-11-07
1699401623123506K053572C. DIFF QUIK CHEKMCB2006-04-26
430881623123506K053572C. DIFF QUIK CHEKMCB2006-04-26
1699401806694917K052932CRYPTOSPORIDIUM IIMHJ2005-11-04
430881806694917K052932CRYPTOSPORIDIUM IIMHJ2005-11-04
1699401350181721K051929GIARDIA/CRYPTOSPORIDIUM CHEKMHJ2005-11-17
430881350181721K051929GIARDIA/CRYPTOSPORIDIUM CHEKMHJ2005-11-17
430881154724035K050891TOX A/B QUICK CHEKLLH2005-07-25
1699401154724035K050891TOX A/B QUICK CHEKLLH2005-07-25
1699401147022708K042071IBD-SCANDEG2004-10-20
430881147022708K042071IBD-SCANDEG2004-10-20
1699401140591935K033274GIARDIA IIMHI2003-11-04
430881140591935K033274GIARDIA IIMHI2003-11-04
430881904209872K030992C. DIFF CHEK - 60LLH2003-07-11
1699401904209872K030992C. DIFF CHEK - 60LLH2003-07-11
1699401219464043K030704IBD-QUIK CHEKDEG2003-04-21
430881219464043K030704IBD-QUIK CHEKDEG2003-04-21
1699401328073993K011396IBD-CHEKDEG2001-06-18
430881328073993K011396IBD-CHEKDEG2001-06-18
1699401244665150K003306C. DIFFICILE TOX A/B IILLH2000-11-22
430881244665150K003306C. DIFFICILE TOX A/B IILLH2000-11-22
1699401264848837
430881264848837
1699401513785088
430881513785088
1699401835312618
430881835312618
1699402022510556
430882022510556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLH112009-03-26
DEG102007-12-04
MHJ62017-07-10
LYR42018-08-21
LQP42018-01-22
KHW42017-06-07
GMZ42012-10-02
MHI42011-08-18
NBT22007-11-07
MCB22006-04-26

PMN#

LEUKO EZ VUE

2007-12-04

TECHLAB INC., CORPORATE RESEARCH CENTER

ASCA-CHEK

2007-11-07

TECHLAB INC., CORPORATE RESEARCH CENTER

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.

TECHLAB, INC.

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.

TECHLAB, INC.

2019-05-31

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

2019-04-12

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.

TECHLAB, INC.

2018-09-28

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

2019-08-06

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.

TECHLAB, INC.

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.

TECHLAB, INC.

2019-05-30

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.

TECHLAB, INC.

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.

TECHLAB, INC.

2019-05-29

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

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.

TECHLAB, INC.

2018-09-28

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