Is this your brand? Sign in to claim ownership.

Immucor GTI Diagnostics, Inc.

United States·US-MF-000020921

Last updated September 17, 2026

Information

Country: United States
Address: 20925, Crossroads Circle, Waukesha, United States
Website: immucor.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Amy Cochran
EUDAMED SRN: US-MF-000020921
FDA FEI Number: 2183608
DUNS Number: —

Catalogue (95)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex	628925	FDA UDI	U	Active
Negative Control Serum	403887	FDA UDI	U	Unknown
LIFECODES LSA Class I	265100IVD	FDA UDI	U	Active
LIFECODES Fluoroanalyzer	888302	FDA UDI	Class II	Active
Anti-Human IgG Conjugate	404557	FDA UDI	Class II	Unknown
Dilution Solution	628155	FDA UDI	U	Active
Conjugate Concentrate	628201	FDA UDI	U	Active
Positive Platelet Control (Positive Eluate Control)	404579	FDA UDI	Class II	Unknown
LIFECODES Class II IDv2 for use with Luminex	628223	FDA UDI	U	Active
LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine	628923	FDA UDI	U	Unknown
Positive Serum Control	403625	FDA UDI	Class II	Active
Concentrated Wash (10X)	404563	FDA UDI	U	Active
LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex	628930	FDA UDI	U	Active
LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit for use with Luminex	628927	FDA UDI	U	Active
Positive Control Serum	628208	FDA UDI	U	Unknown
Specimen Diluent	404582	FDA UDI	Class II	Active
Pak12®G	PAK12G	FDA UDI	Class II	Unknown
Positive Serum Control	404597	FDA UDI	Class II	Unknown
Negative Control Serum	628214	FDA UDI	U	Unknown
Negative Serum Control	403623	FDA UDI	Class II	Active
Cell Resuspension and Preservative Solution	404590	FDA UDI	Class II	Unknown
LIFECODES HLA-B SSO Typing Kit for use with Luminex	628915	FDA UDI	U	Unknown
Negative Control Serum	628209	FDA UDI	U	Unknown
Anti-Human IgG Conjugate	403618	FDA UDI	Class II	Active
Pak12®	PAK12	FDA UDI	Class II	Unknown
Anti-Human IgG/A/M Conjugate	404589	FDA UDI	Class II	Unknown
Anti-Human IgG/A/M Conjugate	403619	FDA UDI	Class II	Active
Eluting Solution	404565	FDA UDI	Class II	Unknown
DonorScreen-HLA® Class I and Class II	DSI+II	FDA UDI	U	Active
Positive Serum Control	404598	FDA UDI	Class II	Unknown
Stopping Solution	403603	FDA UDI	Class II	Unknown
Positive Serum Control	404596	FDA UDI	Class II	Unknown
Pak2-LE	PAK2-LE	FDA UDI	Class II	Unknown
LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex	628921	FDA UDI	U	Active
Substrate Buffer	403613	FDA UDI	Class II	Unknown
LIFECODES Wash Buffer	628211	EUDAMEDFDA UDI	Class A	Active
PF4 Concentrated Wash	403624	EUDAMEDFDA UDI	Class A	Active
PF4 Enhanced assay	K201570	FDA 510(k)	Class II	Active
PF4 IgG assay	K201311	FDA 510(k)	Class II	Active
Streptavidin-PE	628511	EUDAMED	Class A	Active
LIFECODES Taq Polymerase	628075	EUDAMEDFDA UDI	Class A	Active
Concentrated Wash	403622	EUDAMEDFDA UDI	Class A	Active
Dilution Solution	628515UDI	EUDAMEDFDA UDI	Class A	Active
Nuclease-Free Water	757003	EUDAMED	Class A	Active
Specimen Diluent	403602	EUDAMEDFDA UDI	Class A	Active

Related Companies

Authorised Representatives

IMMUCOR Medizinische Diagnostik GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.