LIFECODES HLA-A SSO Typing Kit

FDA UDI

Class U (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name: LIFECODES HLA-A SSO Typing Kit FDA UDI
Generic Name: DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name: DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching FDA UDI
Model / Reference: 628911 FDA UDI
Description: DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching FDA UDI

Identifiers

Catalog Number: 628911 FDA UDI
Primary DI / UDI-DI: 10888234400004 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

LIFECODES HLA-A SSO Typing Kit 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

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Immucor GTI Diagnostics, Inc.

Sources (1)

FDA UDI e19958af-5317-41bd-ada9-8cea1b2ace7d 38 fields · synced Jun 8, 2026