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LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine

FDA UDI

Class U (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name
LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine FDA UDI
Generic Name
DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching FDA UDI
Model / Reference
628923 FDA UDI
Description
DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching FDA UDI

Identifiers

Catalog Number
628923 FDA UDI
Primary DI / UDI-DI
10888234400066 FDA UDI
FDA Product Code
MZI FDA UDI
GMDN Term
DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not 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

LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine by Immucor GTI Diagnostics, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

BK130075 also covers:

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 f508b1d0-a33c-449a-89be-d999f1ff9633 38 fields · synced May 30, 2026