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DonorScreen-HLA® Class I and Class II Additional Reagents

FDA UDI

Class U (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name
DonorScreen-HLA® Class I and Class II Additional Reagents FDA UDI
Generic Name
HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors. FDA UDI
Model / Reference
303456 FDA UDI
Description
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors. FDA UDI

Identifiers

Catalog Number
303456 FDA UDI
Primary DI / UDI-DI
10888234500186 FDA UDI
FDA Product Code
MZI FDA UDI
GMDN Term
HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
U FDA UDI
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

No

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: HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)

DonorScreen-HLA® Class I and Class II Additional Reagents by Immucor GTI Diagnostics, Inc. — Class U — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immucor GTI Diagnostics, Inc.

Sources (1)

  • FDA UDI 0dfbc599-1cec-41ca-8b38-ac8c7ac3cf9f 36 fields · synced Jun 1, 2026