Identity
- Trade Name
- CK-NAC Reagent Set FDA UDI
- Generic Name
- Creatine kinase (CK) multiple isoenzyme IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of creatine kinase activity in serum. Serum creatinine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.¹ Determination of creatine kinase and lactate dehydrogenase isoenzymes provides a definitive diagnosis of acute myocardial infarction. FDA UDI
- Model / Reference
- R1 x 120mL, R2 x 30mL FDA UDI
- Description
- For the quantitative determination of creatine kinase activity in serum. Serum creatinine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.¹ Determination of creatine kinase and lactate dehydrogenase isoenzymes provides a definitive diagnosis of acute myocardial infarction. FDA UDI
Identifiers
- Catalog Number
- 501-408 FDA UDI
- Primary DI / UDI-DI
- 00812137011954 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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 Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI bea8e8ce-9184-4e4c-a328-249e31686c2c 36 fields · synced May 30, 2026