Identity
- Trade Name
- Data-Cyte Plus 0.8% FDA UDI
- Generic Name
- Antibody identification panel reagent red blood cell IVD, kit, agglutination FDA UDI
- Device Name
- Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use. FDA UDI
- Model / Reference
- 11x4 ml FDA UDI
- Description
- Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use. FDA UDI
Identifiers
- Catalog Number
- 213654 FDA UDI
- Primary DI / UDI-DI
- 07640137340285 FDA UDI
- GMDN Term
- Antibody identification panel reagent red blood cell IVD, kit, agglutination FDA UDI
Classification
- 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
No
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: Antibody identification panel reagent red blood cell IVD, kit, agglutination
Data-Cyte Plus 0.8% by Medion Grifols Diagnostics AG — 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
- Medion Grifols Diagnostics AG
Sources (1)
- FDA UDI 3729acc2-a705-4930-914a-051f3f480ad0 33 fields · synced May 30, 2026