Identity
- Trade Name
- BC-5D Control FDA UDI
- Generic Name
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
- Model / Reference
- BC-5D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904084169 FDA UDI
- 510(k) Number
- K160606 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Non-blood cell primer/calibrator/control material IVD, reagent 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Non-blood cell primer/calibrator/control material IVD, reagent
BC-5D Control by Shenzhen Mindray Bio-Medical Electronics Co. — 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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI bdda4964-5023-45f6-9dfa-f1f0f2980362 34 fields · synced Jun 8, 2026