Identity
- Trade Name
- Referencells A1 and B FDA UDI
- Generic Name
- Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination FDA UDI
- Device Name
- This configuration of the product contains two (2) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies. FDA UDI
- Model / Reference
- 0002345 FDA UDI
- Description
- This configuration of the product contains two (2) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies. FDA UDI
Identifiers
- Catalog Number
- 0002345 FDA UDI
- Primary DI / UDI-DI
- 10888234000273 FDA UDI
- GMDN Term
- Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) 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: Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Referencells A1 and B by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination.
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- AFFIRMAGEN — Ortho-Clinical Diagnostics
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- Reverse-Cyte 0.8% (A1, B) — Medion Grifols Diagnostics AG
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 7a22a504-c409-4403-864f-76025c018d40 35 fields · synced Jun 1, 2026