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IMMUCOR, INC.

United States·US-MF-000011568

Last updated September 17, 2026

Information

Country: United States
Address: 3130, Gateway Drive, Norcross, United States
Website: www.transfusionandtransplant.werfen.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 770 441 2051
PRRC Contact: Charnelle Thomas
EUDAMED SRN: US-MF-000011568
FDA FEI Number: 1034569
DUNS Number: 061446282

Catalogue (181)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
ImmuAdd	0002008	FDA UDI	Class II	Active
Anti-Kpa Blood Grouping Reagent	0007540	EUDAMEDFDA UDI	Class C	Active
Gamma-clone Anti-Cw (Monoclonal) Blood Grouping Reagent	0004819	EUDAMEDFDA UDI	Class C	Active
GammaZyme-B	0007058	EUDAMEDFDA UDI	Class C	Active
Gamma EGA Kit	0007865	EUDAMEDFDA UDI	Class C	Active
ECHO Lumena	0086998	EUDAMEDFDA UDI	Class A	Active
ImmuLINK®	0064319	EUDAMEDFDA UDI	Class A	Active
GammaZyme-F	0007056	EUDAMEDFDA UDI	Class C	Active
Capture-CMV	K203612	FDA 510(k)	Class II	Active
Cytomegalovirus Antibody Screen	K910003	FDA 510(k)	Class II	Active
Capture-CMV	K183571	FDA 510(k)	Class II	Active
W.A.R.M.(Warm Autoantibody Removal Medium)	W.A.R.M. (Warm Autoantibody Removal Medium)	EUDAMEDFDA UDI	Class C	Active
Gamma Lewis Blood Group Substance	0007702	EUDAMEDFDA UDI	Class C	Active
Specimen Diluent	0066053	EUDAMEDFDA UDI	Class A	Active
RESt (Rabbit Erythrocyte Stroma)	0057316	EUDAMEDFDA UDI	Class C	Active
Galileo Echo	0087000R	EUDAMED	Class A	Active
Anti-Kpb - Blood Grouping Reagent	0007550	EUDAMEDFDA UDI	Class C	Active
Complement Control Cells	0007930	EUDAMEDFDA UDI	Class C	Active
CMT Plates	0089000	EUDAMEDFDA UDI	Class A	Active
Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent	0004817	EUDAMEDFDA UDI	Class C	Active
Anti-IgG, -C3d (Murine Monoclonal); Polyspecific, Gamma-clone	0409703	EUDAMEDFDA UDI	Class C	Active
Freeze-Dried Papain	0057292	EUDAMEDFDA UDI	Class C	Active
Red Blood Cell (RBC) Storage Solution	0005036	EUDAMEDFDA UDI	Class A	Active
Gamma P1 Blood Group Substance	0007700	EUDAMEDFDA UDI	Class C	Active
Anti-Leb (Murine Monoclonal) Gamma-clone Blood Grouping Reagent	0004864	EUDAMEDFDA UDI	Class C	Active
DAT Positive Control Cell (1 x 10 mL)	0066122	EUDAMEDFDA UDI	Class C	Active
Automated C3d plate	0066260	EUDAMED	Class C	Active
Platelet Wash and Storage Solution	0005035	EUDAMEDFDA UDI	Class A	Active
H.P.C. (Human Platelet Concentrate)	0057320	EUDAMEDFDA UDI	Class C	Active
Anti-Lea (Murine Monoclonal) Gamma-clone Blood Grouping Reagent	0004861	EUDAMEDFDA UDI	Class C	Active
Gamma ELU-KIT II	0007861	EUDAMEDFDA UDI	Class C	Active

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Authorised Representatives

IMMUCOR Medizinische Diagnostik GmbH DE

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