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MONOBIND, INC.

United States·US-MF-000021611

Last updated September 17, 2026

Information

Country: United States
Address: 100, North Pointe Drive, Lake Forest, United States
Website: www.monobind.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 949 951 2665
PRRC Contact: Tony Shatola
EUDAMED SRN: US-MF-000021611
FDA FEI Number: 2020726
DUNS Number: 083155515

Catalogue (424)

Page 9 of 9

Device	Model / Reference	Registries	Class	Status
PSA-XS AccuLite CLIA Kit - 96 Wells	8775-300A	EUDAMEDFDA UDI	Class C	Active
CA-125 AccuLite CLIA Kit - 192 wells	3075-300B	EUDAMEDFDA UDI	Class C	Active
CA 15-3 AccuLite CLIA Kit - 96 wells	5675-300A	EUDAMEDFDA UDI	Class C	Active
Free PSA AccuLite CLIA Kit - 192 wells	2375-300B	EUDAMEDFDA UDI	Class C	Active
Free PSA AccuBind ELISA Kit - 192 wells	2325-300B	EUDAMEDFDA UDI	Class C	Active
CA-125 AccuBind ELISA Kit - 192 wells	3025-300B	EUDAMEDFDA UDI	Class C	Active
AFP, CEA & PSA AccuBind VAST ELISA Kit - 480 wells	8425-300D	EUDAMEDFDA UDI	Class C	Active
CA 19-9 AccuLite CLIA Kit - 192 wells	3925-300B	EUDAMEDFDA UDI	Class C	Active
Autoplex® ELISA & CLIA Analyzer	IN006	EUDAMEDFDA UDI	Class A	Active
AFP, CEA & PSA AccuBind VAST ELISA Kit - 192 wells	8425-300B	EUDAMEDFDA UDI	Class C	Active
PSA-XS AccuBind ELISA Kit - 192 Well	8725-300B	EUDAMEDFDA UDI	Class C	Active
CA 15-3 Accubind ELISA Kit - 96 wells	5625-300A	EUDAMEDFDA UDI	Class C	Active
Autoplex® G3 ELISA & CLIA Analyzer	IN006-3	EUDAMEDFDA UDI	Class A	Active
CA 19-9 AccuLite CLIA Kit - 96 wells	3975-300A	EUDAMEDFDA UDI	Class C	Active
AFP, CEA & PSA AccuLite VAST CLIA Kit - 960 wells	8475-300E	EUDAMEDFDA UDI	Class C	Active
CA-125 AccuBind ELISA Kit - 96 wells	3025-300A	EUDAMEDFDA UDI	Class C	Active
Free PSA AccuLite CLIA Kit - 96 wells	2375-300A	EUDAMEDFDA UDI	Class C	Active
CEA NEXT GEN AccuBind ELISA Kit - 192 wells	4625-300B	EUDAMEDFDA UDI	Class C	Active
AFP, CEA & PSA AccuLite VAST CLIA Kit - 480 wells	8475-300D	EUDAMEDFDA UDI	Class C	Active
CEA NEXT GEN AccuLite CLIA Kit - 96 wells	4675-300A	EUDAMEDFDA UDI	Class C	Active
NeoEldex® ELISA Analyzer	IN009	EUDAMEDFDA UDI	Class A	Active
PSA-XS AccuLite CLIA Kit - 192 Wells	8775-300B	EUDAMEDFDA UDI	Class C	Active
CEA NEXT GEN AccuBind ELISA Kit - 96 wells	4625-300A	EUDAMEDFDA UDI	Class C	Active
CA 15-3 AccuLite CLIA Kit - 192 wells	5675-300B	EUDAMEDFDA UDI	Class C	Active

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