Revogene Strep A 410400
Revogene Strep A 410400 is a Class II device made by Meridian Bioscience Inc., listed in FDA GUDID since 15 Jul 2020 (UDI-DI 00840733102325), registry data as of 8 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840733102325 | Date15 Jul 2020 | StatusListed |
Official records
- AccessGUDID record 00840733102325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Revogene Strep A
- Generic name
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
- Model / reference
- 410400
- Primary DI / UDI-DI
- 00840733102325
- FDA product code
- PGX, OOI
- GMDN term
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
- Device class
- Class II
- Regulation number
- 866.2680, 862.2570
- GUDID distribution status
- In Commercial Distribution
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