Identity
- Trade Name
- CK-MB CAL FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
- Device Name
- The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems. FDA UDI
- Model / Reference
- CK2393 FDA UDI
- Description
- The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems. FDA UDI
Identifiers
- Catalog Number
- CK2393 FDA UDI
- Primary DI / UDI-DI
- 05055273201451 FDA UDI
- 510(k) Number
- K123977 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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, calibrator
Ck-Mb Cal 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, calibrator.
- Alinity — Abbott Ireland Diagnostics · Class II
- Dimension Vista® MMB CAL — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® Systems, ACS:180® Systems CKMB Calibrator — Siemens Healthcare Diagnostics · Class II
- Atellica IM CKMB Calibrator — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Dimension® CKI/MBI CAL — Siemens Healthcare Diagnostics · Class II
- CalSet CK-MB — Roche Diagnostics Corp. · Class II
- Elecsys CKMB CalSet — Roche Diagnostics Corp. · Class I
Cleared under the same submission
K123977 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 76b4cd3a-c7bc-43c2-a624-f8638bf22a8f 37 fields · synced Jun 8, 2026