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Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of isoenzyme CK-MB in human serum. FDA UDI
- Model / Reference
- C614-60 FDA UDI
- Description
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of isoenzyme CK-MB in human serum. FDA UDI
Identifiers
- Catalog Number
- C614-60 FDA UDI
- Primary DI / UDI-DI
- 10673486001655 FDA UDI
- 510(k) Number
- K915709 FDA UDI
- FDA Product Code
- CGS 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
Category: Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent.
- CK-MB — Randox Laboratories, Ltd. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692 — Carolina Liquid Chemistries Corp. · Class II
- CK-MB — Randox Laboratories, Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- CKMB UDR — Sentinel Ch. Srl · Class II
- CK-MB — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
K915709 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 II | Pending data |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 0d70b9e1-23c0-4d98-b6dd-2288dc020e2f 37 fields · synced May 30, 2026