Identity
- Trade Name
- Creatine KinaseMB FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 5401763190 FDA UDI
Identifiers
- Catalog Number
- 5401763190 FDA UDI
- Primary DI / UDI-DI
- 04015630926831 FDA UDI
- 510(k) Number
- K951595 FDA UDI
- FDA Product Code
- JHS FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry
Creatine KinaseMB by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K951595 also covers:
- Abuscreen OnLine Barbiturates — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation — Roche Diagnostics Corp.
- Benzodiazepines — Roche Diagnostics Corp.
- Cannabinoids II — Roche Diagnostics Corp.
- Carbamazepine — Roche Diagnostics Corp.
- Creatine KinaseMB — Roche Diagnostics Corp.
- Creatinine Jaff Gen2 — Roche Diagnostics Corp.
- Creatinine Jaffe Gen.2 — Roche Diagnostics Corp.
- Ethanol Gen.2 — Roche Diagnostics Corp.
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 91ab60ce-4682-46de-97d8-5eebf89d728c 35 fields · synced May 29, 2026