Identity
- Trade Name
- BC-RET Hematology Control FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Model / Reference
- BC-RET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904031422 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Full blood count 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Full blood count IVD, control
BC-RET Hematology Control by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (2)
- FDA UDI 25a2dfd5-3ddc-468f-ba35-02189a2e3c96 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026