Identity
- Trade Name
- Beckman Coulter PK CMV-PA SYSTEM Control Set FDA UDI
- Generic Name
- Cytomegalovirus (CMV) total antibody IVD, control FDA UDI
- Model / Reference
- 240226 FDA UDI
Identifiers
- Catalog Number
- PA2302 FDA UDI
- Primary DI / UDI-DI
- 00850212007058 FDA UDI
- FDA Product Code
- MZE FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) total antibody IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Commercial Distribution
- 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
Category: Cytomegalovirus (CMV) total antibody IVD, control
Beckman Coulter PK CMV-PA SYSTEM Control Set by Fujirebio Diagnostics, 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
- Fujirebio Diagnostics, Inc.
Sources (1)
- FDA UDI 3ab6e28b-78c2-452e-915d-7c138c34c45f 36 fields · synced Jun 9, 2026