FDA Registration
Active
🇺🇸 United States
TECHLAB, INC.
Reg #: 3009935129
·
FEI: 3009935129
·
Expires 2026
Products
10
Proprietary Names
30
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- TECHLAB, INC.
- Registration Number
- 3009935129
- FEI Number
- 3009935129
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 20 Corporate Drive
- City
- Radford
- State
- VA
- ZIP
- 24141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011396
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lactoferrin, Antigen, Antiserum, Control | DEG | Class 1 | Immunology | No | 2008-12-18 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 1994-05-19 |
| Antigens, All Types, Escherichia Coli | GMZ | Class 1 | Microbiology | No | 2012-10-17 |
| Cryptosporidium Spp. | MHJ | Class 2 | Microbiology | No | 2017-07-28 |
| Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | KHW | Class 2 | Microbiology | No | 2017-07-28 |
| Giardia Spp. | MHI | Class 2 | Microbiology | No | 2017-07-28 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2018-08-21 |
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2018-01-29 |
| Antigen, C. Difficile | MCB | Class 1 | Microbiology | No | 2008-12-18 |
| Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | NBT | Class 2 | Immunology | No | 2008-12-18 |
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
C. DIFFICILE TOX A/B II
GIARDIA II
LEUKO EZ VUE
CAMPYLOBACTER CHEK
Establishment Types
Manufacture Medical Device