Giardia II 30405
Giardia II 30405 is a Class II device made by Techlab, Inc., cleared under FDA 510(k) K033274 on 4 Nov 2003 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 00857031002028), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00857031002028 | Date23 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033274 | Date4 Nov 2003 | StatusActive |
Official records
- AccessGUDID record 00857031002028
- FDA 510(k) database K033274
Across registries
- FDA 510(k) K033274 decided 4 Nov 2003 Active
- FDA GUDID UDI-DI 00857031002028 listed 23 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K033274
- Listed FDA GUDID 00857031002028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Giardia II
- Generic name
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- 30405
- Primary DI / UDI-DI
- 00857031002028
- 510(k) Number
- FDA product code
- MHI
- GMDN term
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3220
- GUDID distribution status
- In Commercial Distribution
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