Identity
- Trade Name
- ARGENE® CINAkit HCMV ppUL83 US FDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the qualitative detection of CMV pp65 antigen by indirect immunofluore scence FDA UDI
- Model / Reference
- 19-0028US FDA UDI
- Description
- Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the qualitative detection of CMV pp65 antigen by indirect immunofluore scence FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026390273 FDA UDI
- 510(k) Number
- K982311 FDA UDI
- FDA Product Code
- GQH FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
ARGENE® CINAkit HCMV ppUL83 US by Biomerieux , Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 8eeb3922-77fe-45d3-85de-a8f14e50d652 36 fields · synced May 30, 2026