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Sign in to claim this brandTECHLAB, INC.
United States·US-MF-000008412
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2001, Kraft Drive, BLACKSBURG, United States
- Website
- www.techlab.com
- —
- —
- [email protected]
- Phone
- +1 540-953-1664
- PRRC Contact
- Carlyn Ruble
- EUDAMED SRN
- US-MF-000008412
- FDA FEI Number
- 1000123404
- DUNS Number
- 614218634
Catalogue (91)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| C. Difficile Tox A/B Ii | T5015XB | FDA UDI | Class I | Active |
| Leuko Ez Vue | T30355 | FDA UDI | Class I | Active |
| Lactoferrin Chek | 30352 | FDA UDI | Class I | Active |
| Lactoferrin Ez Vue | 30353 | FDA UDI | Class I | Active |
| C. Difficile Tox-B Test | 30399U | FDA UDI | Class I | Unknown |
| Lactoferrin Chek | T5008 | FDA UDI | Class I | Active |
| H. Pylori Quik Chek | K181379 | FDA 510(k) | Class I | Active |
| Crypto/Giardia-Cel If Test | K955897 | FDA 510(k) | Class II | Active |
| Clostridium Difficile Tox-A-Test | K914902 | FDA 510(k) | Class I | Active |
| Clostridium Difficile Toxin/Antitoxin Kit | K923463 | FDA 510(k) | Class I | Active |
| Cryptosporidium Ii | K052932 | FDA 510(k) | Class II | Active |
| E. Histolytica Test | K955895 | FDA 510(k) | Class II | Active |
| Clostridium Difficile Tox-B Test | K935296 | FDA 510(k) | Class I | Active |
| Techlab Asca-Chek | K051927 | FDA 510(k) | Class II | Active |
| Campylobacter Quik Chek | K191456 | FDA 510(k) | Class I | Active |
| Ibd-Quik Chek | K030704 | FDA 510(k) | Class I | Active |
| C. Difficile Tox A/B Ii | K003306 | FDA 510(k) | Class I | Active |
| Crypto-Cel If Test | K955852 | FDA 510(k) | Class II | Active |
| Giardia Ii | K033274 | FDA 510(k) | Class II | Active |
| H. Pylori Chek™ | K181400 | FDA 510(k) | Class I | Active |
| Campylobacter Quik Chek | K173217 | FDA 510(k) | Class I | Active |
| Ibd-Scan | K042071 | FDA 510(k) | Class I | Active |
| Campylobacter Chek | K173219 | FDA 510(k) | Class I | Active |
| E. Histolytica Quik Chek | K170728 | FDA 510(k) | Class II | Active |
| Cryptosporidium Test | K980354 | FDA 510(k) | Class II | Active |
| C. Difficile Tox A/B Ii | K030404 | FDA 510(k) | Class I | Active |
| Tox A/B Test | K971182 | FDA 510(k) | Class I | Active |
| Techlab 1-Hour Tox-A-Test | K931129 | FDA 510(k) | Class I | Active |
| Fast'n'flammatory Kit | K931241 | FDA 510(k) | Class I | Active |
| Leuko-Test | K951101 | FDA 510(k) | Class I | Active |
| Campylobacter Chek | K191442 | FDA 510(k) | Class I | Active |
| Ibd-Chek | K011396 | FDA 510(k) | Class I | Active |
| Giardia Celisa | K963135 | FDA 510(k) | Class II | Active |
| C. Diff Chek - 60 | K030992 | FDA 510(k) | Class I | Active |
| E. Histolytica Ii | K994101 | FDA 510(k) | Class II | Active |
| Tri-Combo Parasite Screen | K171078 | FDA 510(k) | Class II | Active |
| Giardia/Cryptosporidium Chek | K051929 | FDA 510(k) | Class II | Active |
| C. Diff Chek - 30 | K030991 | FDA 510(k) | Class I | Active |
| Entamoeba Test | K944791 | FDA 510(k) | Class II | Active |
| Tox A/B Quick Chek | K050891 | FDA 510(k) | Class I | Active |
| C. Diff Quik Chek Complete | T30525C | EUDAMEDFDA UDI | Class B | Active |
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