Identity
- Trade Name
- CK NAC FDA UDI
- Generic Name
- Creatine kinase (CK) multiple isoenzyme IVD, reagent FDA UDI
- Device Name
- The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma. FDA UDI
- Model / Reference
- CK110 FDA UDI
- Description
- The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- CK110 FDA UDI
- Primary DI / UDI-DI
- 05055273201390 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 Nac by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Creatine kinase (CK) multiple isoenzyme IVD, reagent.
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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 fee87fae-ec6f-4db3-a39d-f79d43506c8e 37 fields · synced Jun 6, 2026