Identity
- Trade Name
- Panocell-10, Ficin-Treated 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. Panocell-10, Ficin-Treated is a 12-vial set of 10 vials of red blood cells, plus one vial each of Ficin Solution and Ficin Control. FDA UDI
- Model / Reference
- 0002385 FDA UDI
- Description
- This product is used in the identification of unexpected red cell blood group antibodies. Panocell-10, Ficin-Treated is a 12-vial set of 10 vials of red blood cells, plus one vial each of Ficin Solution and Ficin Control. FDA UDI
Identifiers
- Catalog Number
- 0002385 FDA UDI
- Primary DI / UDI-DI
- 10888234000310 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, Ficin-Treated by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antibody identification panel reagent red blood cell IVD, kit, agglutination.
- Biotestcell®-I 11 — Bio-Rad Medical Diagnostics GmbH
- ALBAcyte Expanded Rh Negative Antibody Screen — ALBA BIOSCIENCE LIMITED
- RESOLVE — Ortho-Clinical Diagnostics
- IH-Panel 11 Papain — Bio-Rad Medical Diagnostics GmbH
- Data-Cyte Plus 0.8% — Medion Grifols Diagnostics AG
- RESOLVE — Ortho-Clinical Diagnostics
- Data-Cyte Extend 0.8% — Medion Grifols Diagnostics AG
- ALBAcyte 2-3% Reagent RBCs for Antibody Identification Panels (papain-treated) — ALBA BIOSCIENCE LIMITED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI a8970295-709f-41e2-92ff-9089c364c7c9 35 fields · synced May 30, 2026