Identity
- Trade Name
- CK-MB Test FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the Quantitative Determination of Creatine Kinase-MB (CK-MB) in Serum for Manual and/or Automated Procedures. FDA UDI
- Model / Reference
- 0980-103 FDA UDI
- Description
- For the Quantitative Determination of Creatine Kinase-MB (CK-MB) in Serum for Manual and/or Automated Procedures. FDA UDI
Identifiers
- Catalog Number
- 0980-103 FDA UDI
- Primary DI / UDI-DI
- 00657498000748 FDA UDI
- FDA Product Code
- JHW 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
- Not 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
CK-MB Test by Stanbio Laboratory, L.p. — 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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 2398aad5-e821-4319-a8c4-6ed9a6359449 37 fields · synced Jun 6, 2026