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Capture-R Ready-Screen (I and II)

FDA UDI

by Immucor, Inc.

Identity

Trade Name
Capture-R Ready-Screen (I and II) FDA UDI
Generic Name
Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
Device Name
Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens. 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
0006440 FDA UDI
Description
Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens. 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
0006440 FDA UDI
Primary DI / UDI-DI
10888234000648 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 (I and II) 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immucor, Inc.

Sources (1)

  • FDA UDI b3e21ab5-6e40-44eb-a7e1-d02622454659 35 fields · synced May 30, 2026