Identity
- Trade Name
- ORTHO FDA UDI
- Generic Name
- Antibody screening reagent red blood cell IVD, kit, agglutination FDA UDI
- Device Name
- ORTHO® Pooled Screening Cells FDA UDI
- Model / Reference
- 719000 FDA UDI
- Description
- ORTHO® Pooled Screening Cells FDA UDI
Identifiers
- Catalog Number
- 719000 FDA UDI
- Primary DI / UDI-DI
- 10758750003822 FDA UDI
- GMDN Term
- Antibody screening 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
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 screening reagent red blood cell IVD, kit, agglutination
Ortho by Ortho-Clinical Diagnostics — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antibody screening reagent red blood cell IVD, kit, agglutination.
- Search-Cyte TCS 3% — Medion Grifols Diagnostics AG
- ALBAcyte Reagent RBCs for Reverse Grouping, Antibody Screen (untreated) — ALBA BIOSCIENCE LIMITED
- Biotestcell® 3 — Bio-Rad Medical Diagnostics GmbH
- Panoscreen I, II, and III — IMMUCOR, INC.
- ALBAcyte Antibody Screen (2-Cell) — ALBA BIOSCIENCE LIMITED
- Panoscreen I and II — IMMUCOR, INC.
- Panoscreen I and II — IMMUCOR, INC.
- IH-Cell I-II-III — Bio-Rad Medical Diagnostics GmbH
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
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI e2a55b8f-bbc4-487c-969b-b8981279631f 35 fields · synced May 30, 2026