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Haematology Control - Level 2 (haem Cntl - Level 2)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- HAEMATOLOGY CONTROL - LEVEL 2 (HAEM CNTL - LEVEL 2) FDA UDI
- Generic Name
- Multiple immunohaematology test IVD, control FDA UDI
- Model / Reference
- HM10191 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273215625 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Multiple immunohaematology test IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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 immunohaematology test IVD, control
Haematology Control - Level 2 (haem Cntl - Level 2) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI a728f8eb-ecca-4450-89ca-1bd8ba701f43 32 fields · synced Jun 1, 2026