Identity
- Trade Name
- Elecsys CYFRA 21-1 FDA UDI
- Generic Name
- Cytokeratin IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 07299966190 FDA UDI
Identifiers
- Catalog Number
- 07299966190 FDA UDI
- Primary DI / UDI-DI
- 04015630940004 FDA UDI
- 510(k) Number
- K160915 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
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
No
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: Cytokeratin IVD, kit, chemiluminescent immunoassay
Elecsys CYFRA 21-1 by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytokeratin IVD, kit, chemiluminescent immunoassay.
- CYFRA 21-1 EIA — Fujirebio Diagnostics, Inc. · Class II
- Elecsys CYFRA 21-1 — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K160915 also covers:
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 2c230379-4130-4dba-8aa1-0089abea12e5 35 fields · synced May 30, 2026