TECHLAB, INC.

FDA Device Registration & Listing · BLACKSBURG, VA, US · Registration 1122855

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
1122855
FEI Number
1000123404
Entity Name
TECHLAB, INC.
City/State/Country
BLACKSBURG, VA, US
Establishment Address
2001 KRAFT DRIVE, BLACKSBURG, VA 24060, 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
K053572
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2018-08-21
DEG Lactoferrin, Antigen, Antiserum, Control Immunology Class 1 866.5570 2008-12-18
DEG Lactoferrin, Antigen, Antiserum, Control Immunology Class 1 866.5570 2008-12-18
DEG Lactoferrin, Antigen, Antiserum, Control Immunology Class 1 866.5570 2008-12-18
NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) Immunology Class 2 866.5785 2008-12-18
LQP Campylobacter Spp. Microbiology Class 1 866.3110 2018-01-29
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
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2009-12-17
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2008-01-14
GMZ Antigens, All Types, Escherichia Coli Microbiology Class 1 866.3255 2012-10-17
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Microbiology Class 2 866.3220 2017-07-28
GMZ Antigens, All Types, Escherichia Coli Microbiology Class 1 866.3255 2012-10-17
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
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2008-12-18
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
MCB Antigen, C. Difficile Microbiology Class 1 866.2660 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
3009935129 TECHLAB, INC. Radford, 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.

Similar Registrations

Registration Number Establishment Name Location
1318354 Trinity Biotech USA Jamestown, NY, US
1524213 MERIDIAN BIOSCIENCE, INC. Cincinnati, OH, US
2242436 ZEUS SCIENTIFIC LLC BRANCHBURG, NJ, US
1924669 REMEL, INC. LENEXA, KS, US
3011367240 AXXIN PTY LTD Eaglemont Victoria, AU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1122855. Last updated year: 2026. Please use registration number 1122855 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.