MERIFLUOR Chlamydia 500111
MERIFLUOR Chlamydia 500111 is a Class I device made by Meridian Bioscience Inc., cleared under FDA 510(k) K830342 on 4 May 1983 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00840733101205), active as of 8 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 | Number00840733101205 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK830342 | Date4 May 1983 | StatusActive |
Official records
- AccessGUDID record 00840733101205
- FDA 510(k) database K830342
Across registries
- FDA 510(k) K830342 decided 4 May 1983 Active
- FDA GUDID UDI-DI 00840733101205 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K830342
- Listed FDA GUDID 00840733101205
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MERIFLUOR Chlamydia
- Generic name
- Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 500111
- Primary DI / UDI-DI
- 00840733101205
- 510(k) Number
- FDA product code
- LKI
- GMDN term
- Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay
- Device class
- Class I
- Regulation number
- 866.3120
- GUDID distribution status
- In Commercial Distribution
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