Identity
- Trade Name
- CPK / COLORIMETRIC FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, reagent FDA UDI
- Device Name
- CREATINE PHOSPHOKINASE (CPK) COLORIMETRIC FDA UDI
- Model / Reference
- 2155-0 FDA UDI
- Description
- CREATINE PHOSPHOKINASE (CPK) COLORIMETRIC FDA UDI
Identifiers
- Catalog Number
- 2155-0 FDA UDI
- Primary DI / UDI-DI
- 00852223007034 FDA UDI
- GMDN Term
- Total creatine kinase (CK) IVD, reagent FDA UDI
Classification
- 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: Total creatine kinase (CK) IVD, reagent
Cpk / Colorimetric by Sterling Diagnostics Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total creatine kinase (CK) IVD, reagent.
- Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set — TECO DIAGNOSTICS · Class II
- ARCHITECT — Abbott · Class II
- IDG/Sanzay — IDG/SANZAY Corporation · Class II
- ClearChem Diagnostics Inc. Creatine Kinase (CK) — CLEARCHEM DIAGNOSTICS INC. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC Matrix — TECO DIAGNOSTICS · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sterling Diagnostics Inc
Sources (1)
- FDA UDI 087b032e-82b6-4b16-928d-2226de5118c7 34 fields · synced May 30, 2026