Identity
- Trade Name
- Elecsys CKMB CalSet FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
- Model / Reference
- 5957664190 FDA UDI
Identifiers
- Catalog Number
- 5957664190 FDA UDI
- Primary DI / UDI-DI
- 04015630928736 FDA UDI
- 510(k) Number
- K132571 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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, calibrator
Elecsys CKMB CalSet by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Dimension® MMB Calibrator — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI edd71d72-3c6a-482b-802b-f78b19c49e0c 35 fields · synced May 31, 2026