K610611-2
K610611-2 is a Class II device made by Oxoid Limited, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05700573075706), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05700573075706 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05700573075706
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Herpes simplex virus 1 & 2 (HSV1 & 2) total antibody IVD, kit, fluorescent immunoassay
- Model / reference
- K610611-2
- Primary DI / UDI-DI
- 05700573075706
- FDA product code
- GQN
- GMDN term
- Herpes simplex virus 1 & 2 (HSV1 & 2) total antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.3305
- GUDID distribution status
- In Commercial Distribution
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