Identity
- Trade Name
- Panocell-10 FDA UDI
- Generic Name
- Antibody identification panel reagent red blood cell IVD, kit, agglutination FDA UDI
- Device Name
- This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 10 vials of reagent red blood cells in a set, as well as one (1) Tech Cell and also one (1) buffered preservation diluent. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution. FDA UDI
- Model / Reference
- 0003032 FDA UDI
- Description
- This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 10 vials of reagent red blood cells in a set, as well as one (1) Tech Cell and also one (1) buffered preservation diluent. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution. FDA UDI
Identifiers
- Catalog Number
- 0003032 FDA UDI
- Primary DI / UDI-DI
- 10888234000396 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
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
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
Panocell-10 by Immucor, Inc. — 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
- Immucor, Inc.
Sources (1)
- FDA UDI 3556d0b6-3926-4b32-8ca7-7ce6e8f1ce29 35 fields · synced May 30, 2026