Identity
- Trade Name
- ABX PENTRA CK CONTROL FDA UDI
- Generic Name
- Creatine kinase (CK) multiple isoenzyme IVD, control FDA UDI
- Model / Reference
- 1220001786 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005545 FDA UDI
- 510(k) Number
- K062737 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Creatine kinase (CK) multiple isoenzyme IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Abx Pentra Ck Control by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K062737 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 I | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI cda26835-4bff-40a3-876b-f1fda62042c0 34 fields · synced May 30, 2026