Identity
- Trade Name
- Erytype S ABO Confirm FDA UDI
- Generic Name
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- Blood Grouping Reagent; Erytype S ABO Confirm; Microplate for ABO donor unit confirmation with TANGO instruments; contains Anti-A (A003) and Anti-B (B005); 10 Plates FDA UDI
- Model / Reference
- 806130100 FDA UDI
- Description
- Blood Grouping Reagent; Erytype S ABO Confirm; Microplate for ABO donor unit confirmation with TANGO instruments; contains Anti-A (A003) and Anti-B (B005); 10 Plates FDA UDI
Identifiers
- Catalog Number
- 806130100 FDA UDI
- Primary DI / UDI-DI
- 07611969965670 FDA UDI
- GMDN Term
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
Classification
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
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: ABO/Rh multiple blood grouping IVD, kit, agglutination
Erytype S ABO Confirm by Bio-Rad Medical Diagnostics GmbH — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 11984af1-5c35-4135-85ec-47763455ae2c 35 fields · synced May 30, 2026