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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. FDA UDI
Model / Reference
0006439 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. FDA UDI

Identifiers

Catalog Number
0006439 FDA UDI
Primary DI / UDI-DI
10888234000631 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

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

No

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: 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 43bbfb83-6d4b-4e29-b451-5c3421a18bfd 36 fields · synced May 30, 2026