Vidas® 99735R
Vidas® 99735R is a Class II device made by Biomerieux SA, cleared under FDA 510(k) K891385 on 18 Apr 1989 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 03573026152482), active as of 12 Nov 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 | Number03573026152482 | Date14 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK891385 | Date18 Apr 1989 | StatusActive |
Official records
- AccessGUDID record 03573026152482
- FDA 510(k) database K891385
Across registries
- FDA 510(k) K891385 decided 18 Apr 1989 Active
- FDA GUDID UDI-DI 03573026152482 listed 14 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K891385
- Listed FDA GUDID 03573026152482
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vidas®
- Generic name
- Fluorescent immunoassay analyser IVD, laboratory
- Model / reference
- 99735R
- Primary DI / UDI-DI
- 03573026152482
- 510(k) Number
- FDA product code
- DEW
- GMDN term
- Fluorescent immunoassay analyser IVD, laboratory
- Device class
- Class II
- Regulation number
- 866.5510
- GUDID distribution status
- In Commercial Distribution
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