Rapid Response ROT-9C20
by BTNX Inc
Rapid Response ROT-9C20 is a Class I device made by BTNX Inc, cleared under FDA 510(k) K990842 on 9 Aug 1999 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00722066001899), 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 | Number00722066001899 | Date25 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK990842 | Date9 Aug 1999 | StatusActive |
Official records
- AccessGUDID record 00722066001899
- FDA 510(k) database K990842
Across registries
- FDA 510(k) K990842 decided 9 Aug 1999 Active
- FDA GUDID UDI-DI 00722066001899 listed 25 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K990842
- Listed FDA GUDID 00722066001899
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid Response
- Generic name
- Rotavirus antigen IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- ROT-9C20
- Primary DI / UDI-DI
- 00722066001899
- 510(k) Number
- FDA product code
- LIQ
- GMDN term
- Rotavirus antigen IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 866.3405
- GUDID distribution status
- In Commercial Distribution
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