Identity
- Trade Name
- CK-MB FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent FDA UDI
- Device Name
- The device is intended for the quantitative in vitro determination of CK-MB concentration in serum or plasma. FDA UDI
- Model / Reference
- CK1296 FDA UDI
- Description
- The device is intended for the quantitative in vitro determination of CK-MB concentration in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- CK1296 FDA UDI
- Primary DI / UDI-DI
- 05055273201420 FDA UDI
- 510(k) Number
- K951223 FDA UDI
- FDA Product Code
- CGS FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent 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
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
No
FDA UDI
Category: Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
Ck-Mb by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent.
- i-STAT — Abbott Point of Care Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692 — Carolina Liquid Chemistries Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set — TECO DIAGNOSTICS · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- CKMB UDR — Sentinel Ch. Srl · Class II
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set — TECO DIAGNOSTICS · Class II
- CK-MB — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
K951223 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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI b2815b02-0434-498b-ad93-530a6580a032 37 fields · synced May 29, 2026