Identity
- Trade Name
- IH-Card ABO Neutral FDA UDI
- Generic Name
- Column agglutination IVD FDA UDI
- Device Name
- The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells. FDA UDI
- Model / Reference
- 12008722 FDA UDI
- Description
- The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells. FDA UDI
Identifiers
- Catalog Number
- 12008722 FDA UDI
- Primary DI / UDI-DI
- 03610522055685 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Column agglutination IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 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
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
Category: Column agglutination IVD
IH-Card ABO Neutral by Bio-Rad Medical Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Column agglutination IVD.
- Drew — Drew Scientific , Ltd. · Class II
- DG Gel 8 Neutral — DIAGNOSTIC GRIFOLS SA · Class II
- MTS — MICRO TYPING SYSTEMS, 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 cc66ca6a-b6c2-4fc1-9938-ca0481c62616 37 fields · synced Jun 1, 2026