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LGC Clinical Diagnostics, Inc.

United States·US-MF-000016356

Last updated September 17, 2026

Information

Country: United States
Address: 221 US Route 1, Cumberland Foreside , United States
Website: lgcgroup.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 207 892 1300
PRRC Contact: David Larrivee
EUDAMED SRN: US-MF-000016356
FDA FEI Number: 1220394
DUNS Number: —

Catalogue (339)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
Optitrol NAT HBV Screening, 10x 1, 2 mL	NT01012	EUDAMED	Class B	Active
Optitrol Paediatric G-2, 2x pos, 2, 5mL	SR15027	EUDAMED	Class B	Active
Optitrol Chagas-1, 1x pos, 1mL	SR16025	EUDAMED	Class B	Active
Optitrol Yellow, 1x pos, 1mL	SR11029	EUDAMED	Class B	Active
Optitrol Red, 1x pos, 1mL	SR11059	EUDAMED	Class B	Active
Optitrol NAT HCV Screening, 10x 1, 2 mL	NT01022	EUDAMED	Class B	Active
Optitrol HIV p24, 4x pos, 2.5mL	SR11103	EUDAMED	Class B	Active
Optitrol HEPR-2, 2x pos, 2.5mL	SR12057	EUDAMED	Class B	Active
Optitrol HIV 2, 2x pos, 2.5mL	SR11117	EUDAMED	Class B	Active
Optitrol NAT NEG, 5x 1, 2 mL	NT01051	EUDAMED	Class B	Active
Optitrol NAT NEG, 10x 1, 2 mL	NT01052	EUDAMED	Class B	Active
Optitrol SeroNeg, 4x neg, 1mL	SR11000	EUDAMED	Class B	Active
Optitrol Orange, 2x pos, 5mL	SR11063	EUDAMED	Class B	Active
Optitrol Orange, 4x pos, 5mL	SR11061	EUDAMED	Class B	Active
Optitrol NAT Triplex, 10x 1, 2 mL	NT01042	EUDAMED	Class B	Active
Optitrol Yellow, 2x pos, 5mL	SR11023	EUDAMED	Class B	Active
Optitrol Mumps M, 1x pos, 1mL	SR15065	EUDAMED	Class B	Active
Optitrol NAT HIV Screening, 10x 1, 2 mL	NT01032	EUDAMED	Class B	Active
Optitrol Chagas-1, 2x pos, 2.5mL	SR16027	EUDAMED	Class B	Active
Optitrol Paediatric G negative, 2x neg, 2, 5mL	SR15006	EUDAMED	Class B	Active
Optitrol HEPA-1, 1x pos, 1mL	SR12025	EUDAMED	Class B	Active
Optitrol Paediatric G-2, 1x pos, 1mL	SR15025	EUDAMED	Class B	Active
Optitrol HIV 2, 1x pos, 1mL	SR11115	EUDAMED	Class B	Active
Optitrol Blue	SR11011	EUDAMED	Class B	Active
Optitrol Mumps M, 2x pos, 1mL	SR15068	EUDAMED	Class B	Active
Optitrol NAT HBV Screening, 5x 1, 2 mL	NT01011	EUDAMED	Class B	Active
Optitrol Orange, 1x pos, 1mL	SR11069	EUDAMED	Class B	Active
Optitrol Blue	SR11013	EUDAMED	Class B	Active
Optitrol HEPA-1, 2x pos, 2.5mL	SR12027	EUDAMED	Class B	Active
Optitrol NAT Parvo B19, 5x 1.2 mL	NT05021	EUDAMED	Class B	Active
Optitrol NAT HIV-2, 5x 1, 2 mL	NT01035	EUDAMED	Class B	Active
Optitrol SeroNeg, 2x neg, 1mL	SR11001	EUDAMED	Class B	Active
Optitrol NAT Parvo B19, 10x 1, 2 mL	NT05022	EUDAMED	Class B	Active
Optitrol Chagas-2, 1x pos, 1mL	SR16035	EUDAMED	Class B	Active
Optitrol HEPA-2, 1x pos, 1mL	SR12035	EUDAMED	Class B	Active
Optitrol Blue	SR11019	EUDAMED	Class B	Active
Optitrol NAT HIV-2, 10x 1, 2 mL	NT01036	EUDAMED	Class B	Active
Optitrol NAT Triplex, 5x 1, 2 mL	NT01041	EUDAMED	Class B	Active
Optitrol HEPR-2, 1x pos, 1mL	SR12055	EUDAMED	Class B	Active
Optitrol Red, 2x pos, 5mL	SR11053	EUDAMED	Class B	Active
Optitrol Red, 4x pos, 5mL	SR11051	EUDAMED	Class B	Active
Optitrol HEPA-2, 2x pos, 2.5mL	SR12037	EUDAMED	Class B	Active
Optitrol Yellow 4x5 mL	SR11021	EUDAMED	Class B	Active
Optitrol HIV p24, 4x pos, 5mL	SR11101	EUDAMED	Class B	Active
Optitrol HIV p24, 2x pos, 2.5mL	SR11107	EUDAMED	Class B	Active
Accurun®	2000-0032	FDA UDI	Class II	Active
FT4 Install Kit	C-1002ro	FDA UDI	Class I	Active
NTproBNP Install Kit	C-1001ro	FDA UDI	Class I	Active
Validate	204ro	FDA UDI	Class I	Active
ACCURUN® 2 Series 5600	2000-0100	FDA UDI	Class I	Active

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