Identity
- Trade Name
- COAGULATION CALIBRATOR (COAG CAL) FDA UDI
- Generic Name
- Multiple coagulation factor IVD, calibrator FDA UDI
- Model / Reference
- CG5037 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273208405 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
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 coagulation factor IVD, calibrator
Coagulation Calibrator (coag Cal) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple coagulation factor IVD, calibrator.
- CA CAL S — Sysmex Corp. · Class II
- CA CAL S — Sysmex Corp. · Class II
- CRYOcheck™ Normal Reference Plasma — Precision Biologic · Class II
- TriniVerical™ — TCOAG IRELAND LIMITED · Class I
- CRYOcheck™ Normal Reference Plasma — Precision Biologic · Class II
- VisuCal-F Frozen Calibrator Plasma — Affinity Biologicals Inc · Class II
- Standard Human Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Standard Human Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 04845b85-4896-4c10-84ab-23255caea9b7 32 fields · synced Jun 1, 2026