Identity
- Trade Name
- EIA Test Kit FDA UDI
- Generic Name
- Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- BC-1065 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867556000188 FDA UDI
- GMDN Term
- Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) 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
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: Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
EIA Test Kit by Critical Care Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA).
- Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge — Siemens Healthcare Diagnostics · Class II
- Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge — Siemens Healthcare Diagnostics · Class II
- Dimension Vista® Flex® reagent cartridge MBI — Siemens Healthcare Diagnostics · Class II
- EIA Test Kit — CRITICAL CARE DIAGNOSTICS, INC.
- Presage ST2 Assay Kit — CRITICAL CARE DIAGNOSTICS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Critical Care Diagnostics, Inc.
Sources (1)
- FDA UDI b4eaff6b-e116-484a-934f-9e8accfb81e0 33 fields · synced May 30, 2026