Identity
- Trade Name
- CKMB UDR FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent FDA UDI
- Device Name
- The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC600, DxC800 and Synchron LX20 systems of the CK-MB isoenzyme activity of creatine kinase in serum and Li-heparin plasma by inhibition method. FDA UDI
- Model / Reference
- A53720 FDA UDI
- Description
- The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC600, DxC800 and Synchron LX20 systems of the CK-MB isoenzyme activity of creatine kinase in serum and Li-heparin plasma by inhibition method. FDA UDI
Identifiers
- Catalog Number
- A53720 FDA UDI
- Primary DI / UDI-DI
- 08058056680297 FDA UDI
- 510(k) Number
- K102706 FDA UDI
- FDA Product Code
- JHS FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) 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
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
Dimensions & Sizes
- Size
- Total Volume — 112 Milliliter FDA UDI
Category: Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
Ckmb Udr by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent.
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- CK-MB — Randox Laboratories, Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set — TECO DIAGNOSTICS · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set — TECO 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 7d8737c3-c7f4-4d35-9ab7-066bd31728a0 38 fields · synced May 30, 2026