Identity
- Trade Name
- PREMIER Rotaclone FDA UDI
- Generic Name
- Rotavirus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens. FDA UDI
- Model / Reference
- 696004 FDA UDI
- Description
- Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens. FDA UDI
Identifiers
- Catalog Number
- 696004 FDA UDI
- Primary DI / UDI-DI
- 00840733101700 FDA UDI
- 510(k) Number
- K852969 FDA UDI
- FDA Product Code
- LIQ FDA UDI
- GMDN Term
- Rotavirus antigen IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)
PREMIER Rotaclone by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 6353a76d-1a7d-4e9d-8faf-69dc2a0e62de 37 fields · synced May 30, 2026