Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Rotavirus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavirus antigens in fecal specimens. FDA UDI
- Model / Reference
- ROT-9C20 FDA UDI
- Description
- Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavirus antigens in fecal specimens. FDA UDI
Identifiers
- Catalog Number
- ROT-9C20 FDA UDI
- Primary DI / UDI-DI
- 00722066001899 FDA UDI
- 510(k) Number
- K990842 FDA UDI
- FDA Product Code
- LIQ FDA UDI
- GMDN Term
- Rotavirus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3405 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rotavirus antigen IVD, kit, rapid ICT, clinical
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotavirus antigen IVD, kit, rapid ICT, clinical.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI d0b552c5-f19e-4a25-829d-ceaa581ba377 35 fields · synced Jun 1, 2026