TECHLAB, INC.

FDA Device Registration & Listing · Radford, VA, US · Registration 3009935129

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009935129
FEI Number
3009935129
Entity Name
TECHLAB, INC.
City/State/Country
Radford, VA, US
Establishment Address
20 Corporate Drive, Radford, VA 24141, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TECHLAB, INC. (Owner Number: 9001581)
Owner / Operator Contact Address
2001 KRAFT DRIVE, Blacksburg, VA 24060, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K071711
PMA Number
N/A

All Registered Proprietary Names

LACTOFERRIN CHEK IBD-CHEK TOX-B TEST SHIGA TOXIN QUIK CHEK IBD-SCAN LACTOFERRIN SCAN C. DIFF CHEK -60 TRI-COMBO PARASITE SCREEN SHIGA TOXIN CHEK H. PYLORI CHEK C. DIFF QUIK CHEK COMPLETE GIARDIA/CRYPTOSPORIDIUM QUIK CHEK CAMPYLOBACTER QUIK CHEK QuickVue TLI Campylobacter TEST C. DIFF QUIK CHEK GIARDIA/CRYPTOSPORIDIUM CHEK E. HISTOLYTICA II QuickVue TLI H. pylori Stool Antigen TEST H. PYLORI QUIK CHEK LACTOFERRIN EZ VUE QuickVue TLI Lactoferrin TEST IBD EZ VUE E. HISTOLYTICA QUIK CHEK TOX A/B QUIK CHEK CRYPTOSPORIDIUM II ASCA-CHEK

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DEG Lactoferrin, Antigen, Antiserum, Control Immunology Class 1 866.5570 2008-12-18
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 1994-05-19
GMZ Antigens, All Types, Escherichia Coli Microbiology Class 1 866.3255 2012-10-17
DEG Lactoferrin, Antigen, Antiserum, Control Immunology Class 1 866.5570 2008-12-18
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2008-12-18
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2017-07-28
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Microbiology Class 2 866.3220 2017-07-28
MHI Giardia Spp. Microbiology Class 2 866.3220 2017-07-28
GMZ Antigens, All Types, Escherichia Coli Microbiology Class 1 866.3255 2012-10-17
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2018-08-21
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2009-12-17
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2011-09-26
MHI Giardia Spp. Microbiology Class 2 866.3220 2011-09-26
LQP Campylobacter Spp. Microbiology Class 1 866.3110 2018-01-29
MCB Antigen, C. Difficile Microbiology Class 1 866.2660 2008-12-18
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2008-12-18
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Microbiology Class 2 866.3220 2008-12-18
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2018-08-21
DEG Lactoferrin, Antigen, Antiserum, Control Immunology Class 1 866.5570 2008-12-18
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Microbiology Class 2 866.3220 2017-07-28
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2008-01-14
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2008-12-18
NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) Immunology Class 2 866.5785 2008-12-18

Official Correspondent

DONNA LINK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TECHLAB, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1122855 TECHLAB, INC. BLACKSBURG, VA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K930451 Alexon, Inc. PROSPEC T GIARDIA MICROTITER ASSAY 1993-04-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0015-2014 Sekisui Diagnostics LLC 1
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009935129. Last updated year: 2026. Please use registration number 3009935129 when referencing this establishment in official correspondence.
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