Identity
- Trade Name
- CYFRA 21-1 EIA FDA UDI
- Generic Name
- Cytokeratin IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 211-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350066140135 FDA UDI
- FDA Product Code
- OVK FDA UDI
- GMDN Term
- Cytokeratin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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
Yes
FDA UDI
Category: Cytokeratin IVD, kit, chemiluminescent immunoassay
Cyfra 21-1 Eia by Fujirebio Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytokeratin IVD, kit, chemiluminescent immunoassay.
- Elecsys CYFRA 21-1 — Roche Diagnostics Corp. · Class II
- Elecsys CYFRA 21-1 — Roche Diagnostics Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujirebio Diagnostics, Inc.
Sources (1)
- FDA UDI 0e097631-a8a3-47da-841d-ea5d211b1f9d 35 fields · synced Jun 9, 2026