Identity
- Trade Name
- IH-500 FDA UDI
- Generic Name
- Immunohaematology/blood bank analyser IVD FDA UDI
- Device Name
- IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens FDA UDI
- Model / Reference
- 001510 FDA UDI
- Description
- IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens FDA UDI
Identifiers
- Catalog Number
- 001510 FDA UDI
- Primary DI / UDI-DI
- 07611969233786 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Immunohaematology/blood bank analyser 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Immunohaematology/blood bank analyser IVD
Ih-500 by Bio-Rad Medical Diagnostics GmbH — 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
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 702edeb7-5b88-43e9-9bbc-d750cb166f2a 34 fields · synced May 31, 2026