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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2018-08-21 |
| Lactoferrin, Antigen, Antiserum, Control | DEG | Class 1 | Immunology | No | 2008-12-18 |
| Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | NBT | Class 2 | Immunology | No | 2008-12-18 |
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2018-01-29 |
| 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 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 2009-12-17 |
| Antigens, All Types, Escherichia Coli | GMZ | Class 1 | Microbiology | No | 2012-10-17 |
| Antigen, C. Difficile | MCB | Class 1 | Microbiology | No | 2008-12-18 |
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