Identity
- Trade Name
- Capture-R Ready-Screen (Pooled Cells) FDA UDI
- Generic Name
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
- Device Name
- Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box. FDA UDI
- Model / Reference
- 0066254 FDA UDI
- Description
- Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box. FDA UDI
Identifiers
- Catalog Number
- 0066254 FDA UDI
- Primary DI / UDI-DI
- 10888234001317 FDA UDI
- GMDN Term
- Solid-phase red blood cell adherence antibody/antigen IVD 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
No
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: Solid-phase red blood cell adherence antibody/antigen IVD
Capture-R Ready-Screen (Pooled Cells) by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Solid-phase red blood cell adherence antibody/antigen IVD.
- Solidscreen II Strip — Bio-Rad Medical Diagnostics GmbH · Class II
- Referencells — IMMUCOR, INC. · U
- Capture-R Control set — IMMUCOR, INC.
- Capture-R Ready-ID Extend I — IMMUCOR, INC.
- Capture-R Ready-Screen 3 — IMMUCOR, INC. · U
- Capture-R Ready-Screen (3) — IMMUCOR, INC.
- Capture-R® Ready-Screen® (I and II) — IMMUCOR, INC.
- Capture-R Ready-Screen (I and II) — IMMUCOR, INC.
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 098ceb20-4aaa-434b-8c17-462ae92d4c88 35 fields · synced May 30, 2026