Identity
- Trade Name
- CK FDA UDI
- Generic Name
- Creatine kinase (CK) multiple isoenzyme IVD, reagent FDA UDI
- Device Name
- The CK method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatine kinase activity in serum or plasma. FDA UDI
- Model / Reference
- CK2813 FDA UDI
- Description
- The CK method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatine kinase activity in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- CK2813 FDA UDI
- Primary DI / UDI-DI
- 05055273201468 FDA UDI
- 510(k) Number
- K923511 FDA UDI
- FDA Product Code
- CGS FDA UDI
- GMDN Term
- Creatine kinase (CK) multiple isoenzyme 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 (CK) multiple isoenzyme IVD, reagent
Ck by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI cff27194-6d3a-4cce-b259-ddd8137f3e2f 37 fields · synced Jun 6, 2026