Identity
- Trade Name
- IH-Basic QC FDA UDI
- Generic Name
- Multiple immunohaematology test IVD, control FDA UDI
- Device Name
- Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System FDA UDI
- Model / Reference
- 814171100 FDA UDI
- Description
- Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07611969952335 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Multiple immunohaematology test IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 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
Yes
FDA UDI
Prescription Use
Yes
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
No
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
IH-Basic QC by Bio-Rad Medical Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple immunohaematology test IVD, control.
- Checkcell (Weak) — IMMUCOR, INC. · Class II
- Checkcell — IMMUCOR, INC. · Class II
- Checkcell (Weak) — IMMUCOR, INC. · Class II
- Monoclonal Control — IMMUCOR, INC. · Class II
- DG Gel Extended Control — Medion Grifols Diagnostics AG
- DG Gel Essential Control — Medion Grifols Diagnostics AG
- Coombs Control Cells — Medion Grifols Diagnostics AG
- Gamma-clone Control — IMMUCOR, INC. · 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
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI dd94a958-19a9-4633-8616-d77502fbd2f7 36 fields · synced May 31, 2026