Identity
- Trade Name
- BC-3D Control FDA UDI
- Generic Name
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
- Model / Reference
- BC-3D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904084145 FDA UDI
- 510(k) Number
- K843962 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-3D Control by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-blood cell primer/calibrator/control material IVD, reagent.
- MQC — HEMO BIOSCIENCE · Class II
- FREND PSA Plus Linearity Kit — NanoEnTek, Inc. · Class I
- Flow-Count 1 x 21mL — Beckman Coulter, Inc. · Class II
- FREND Testosterone Linearity Kit — NanoEnTek, Inc. · Class I
- MQC-CAT — HEMO BIOSCIENCE · Class II
- FREND Vitamin D Linearity Kit — NanoEnTek, Inc. · Class I
- ORTHO Daily QC Simulated Whole Blood Quality Control Kit — MILLIPORE (U.K.) LIMITED · Class II
- FREND TSH Linearity Kit — NanoEnTek, Inc. · Class I
Cleared under the same submission
K843962 also covers:
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI a617e3f2-50bd-4e4a-9b90-8369948d8015 34 fields · synced Jun 1, 2026