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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Gamma PeG	0705003	FDA UDI	Class II	Active
Capture-R Ready-Screen (I and II)	0066207	FDA UDI	N/A	Active
Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin	0012280	FDA UDI	Class II	Active
ImmuLINK	0030311	FDA UDI	Class II	Active
Capture-P	0066246	FDA UDI	Class I	Active
Anti-Cw	0007406	FDA UDI	N/A	Active
Anti-Jka (Monoclonal) Gamma-clone	0004812	FDA UDI	N/A	Active
Anti-Fyb	0007594	FDA UDI	N/A	Active
Anti-N (Murine Monoclonal) Gamma-clone	0004807	FDA UDI	N/A	Active
Anti-C3b, -C3d (Murine Monoclonal) Gamma-clone	0004068	FDA UDI	N/A	Active
Anti-E (Monoclonal) Gamma-clone	0066422	FDA UDI	N/A	Active
Capture-R Ready-Screen (3)	0066805	FDA UDI	N/A	Active
Anti-e (Monoclonal Blend) Gamma-clone	0066424	FDA UDI	N/A	Active
Anti-A (Murine Monoclonal) Series 1	0006401	FDA UDI	N/A	Active
Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent	10 mL size vial / 5mL fill volume	FDA UDI	N/A	Active
Anti-D (Monoclonal Blend) Gamma-clone	0066420	FDA UDI	N/A	Active
Capture-CMV	0066206	FDA UDI	Class II	Active
Anti-A (Murine Monoclonal) Gamma-clone	0410210	FDA UDI	N/A	Active
Anti-A (Murine Monoclonal) Series 1	0006400	FDA UDI	N/A	Active
Capture-P	0066904	FDA UDI	Class I	Active
Gamma-clone Control	0420410	FDA UDI	Class II	Active
NEO Iris	0064597	FDA UDI	Class II	Active
FMH RapidScreen	0007893	FDA UDI	Class II	Active
Hemantigen (Pooled Cells)	0002223	FDA UDI	N/A	Active
Anti-P1 (Murine Monoclonal) Gamma-clone	0004501	FDA UDI	N/A	Active
Anti-D Series 5 (Murine Monoclonal)	0006415	FDA UDI	N/A	Active
Capture-R Ready-ID Extend I	0006454	FDA UDI	N/A	Active
Panoscreen I and II	0002390	FDA UDI	N/A	Active
Capture-P	0066251	FDA UDI	Class I	Active
Capture-R Ready-Screen (I and II)	0006439	FDA UDI	N/A	Active
Checkcell	0002225	FDA UDI	Class II	Active
pHix	0005070	FDA UDI	Class I	Active
Anti-B (Murine Monoclonal) Series 3	0006406	FDA UDI	N/A	Active
Galileo Echo	0087000	FDA UDI	Class II	Active
Capture LISS	0006419	FDA UDI	Class I	Active
Gamma-clone Control	0420403	FDA UDI	Class II	Active
Panoscreen I and II	0002380	FDA UDI	N/A	Active
TPHA Screen Positive Control and TPHA Screen Negative Control	0066828	FDA UDI	Class II	Active
Anti-Jkb (Monoclonal) Gamma-clone	0004813	FDA UDI	N/A	Active
Referencells A1, A2, B and O	0002338	FDA UDI	N/A	Active
Capture-R Ready-Screen (I and II)	0066217	FDA UDI	N/A	Active
Capture-R Ready-Screen (3)	0066813	FDA UDI	N/A	Active
Capture-P Indicator Red Cells	0066906	FDA UDI	Class I	Active
Specimen Diluent	0066052	FDA UDI	Class II	Active
Anti-IgG (Murine Monoclonal) (Uncolored) Gamma-clone	0401510	FDA UDI	N/A	Active
Capture-P Control set	0066248	FDA UDI	Class I	Active
Capture-R Select	0066903	FDA UDI	Class II	Active
Capture-R® Ready-Screen® (I and II)	0066212	FDA UDI	N/A	Active
Capture-R Control set	0066236	FDA UDI	N/A	Active
corQC Test System	0002400	FDA UDI	Class II	Active

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IMMUCOR Medizinische Diagnostik GmbH DE

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