Identity
- Trade Name
- VIDAS® CK-MB FDA UDI
- Generic Name
- Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma. FDA UDI
- Model / Reference
- 30421-01 FDA UDI
- Description
- The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026161613 FDA UDI
- FDA Product Code
- JHX FDA UDI
- GMDN Term
- Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 FDA UDI
- Commercial Distribution
- Not 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
Vidas® Ck-Mb by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 3f0217f8-2f04-4a44-9af7-579fd2eca177 35 fields · synced Jun 8, 2026