FDA Registration Active 🇺🇸 United States

TECHLAB, INC.

Reg #: 1122855 · FEI: 1000123404 · Expires 2026
Products
10
Proprietary Names
30
Establishment Types
1
Classifications
10

Registration Details

Registration Name
TECHLAB, INC.
Registration Number
1122855
FEI Number
1000123404
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
2001 KRAFT DRIVE
City
BLACKSBURG
State
VA
ZIP
24060
Country
US

Regulatory Submissions

510(k) Number
K181379

Owner / Operator

Firm Name
TECHLAB, INC.
Operator Number
9001581
Address
2001 KRAFT DRIVE
City
Blacksburg
State
VA
Postal Code
24060
Country
US
Correspondent
DONNA T LINK

Products

Device Name Product Code
Helicobacter Pylori LYR
Lactoferrin, Antigen, Antiserum, Control DEG
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) NBT
Campylobacter Spp. LQP
Cryptosporidium Spp. MHJ
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. KHW
Giardia Spp. MHI
Reagents, Clostridium Difficile Toxin LLH
Antigens, All Types, Escherichia Coli GMZ
Antigen, C. Difficile MCB

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 CRYPTOSPORIDIUM II GIARDIA II C. DIFF CHEK -60 GIARDIA/CRYPTOSPORIDIUM CHEK CAMPYLOBACTER CHEK GIARDIA/CRYPTOSPORIDIUM QUIK CHEK

Establishment Types

Manufacture Medical Device