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LGC Clinical Diagnostics, Inc.

United States·US-MF-000016356

Last updated September 17, 2026

What LGC Clinical Diagnostics, Inc. makes

LGC Clinical Diagnostics, Inc. manufactures in vitro diagnostic (IVD) controls and reagents for detecting blood-borne viruses, including hepatitis B and C, HIV, and SARS-CoV-2. Their portfolio also includes controls for measuring tau protein, thyroid hormones like free thyroxine (FT4), and prostate-specific antigens (tPSA and fPSA). Clinical chemistry analyte profiles and pediatric diagnostic controls are also part of their offerings, designed for laboratory testing purposes.

The company’s devices are regulated under EU IVD Annex II List B and General categories, as well as FDA Class I and Class II classifications. Their products are listed in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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 3 of 7

Device	Model / Reference	Registries	Class	Status
AccuPlex™ SARS-CoV-2 Molecular Controls kit	0505-0133	FDA UDI	Class I	Unknown
Validate	404ro	FDA UDI	Class I	Active
Accurun®	2000-0006	FDA UDI	Class II	Active
Validate	802re	FDA UDI	Class I	Active
Validate	310ro	FDA UDI	Class I	Active
Validate	309re	FDA UDI	Class I	Active
Accurun®	2010-0025	FDA UDI	N/A	Active
Validate	305re	FDA UDI	Class I	Active
AccuTrak	2400-0254	FDA UDI	Class I	Active
AccuTrak	2400-0253	FDA UDI	Class I	Active
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL	2000-0063	FDA UDI	Class I	Active
VALIDATE® UC1 Test Set	701au	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® BODY FLUIDS Test Set	205bf	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 121 HAV IgM Positive Control	2015-0076	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® D-DIMER Test Set	902il	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CM1 Test Set	401db	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC1 Test Set	701ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC2 Test Set	1200au	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC4 Test Set	704ri	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC2 Test Set	1200ab	EUDAMEDFDA UDI	IVD General	Active
Accurun 1 Series 5100 Positive Control	2000-0017	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CM2 Test Set	402vt	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CM1 Test Set	401ro	EUDAMEDFDA UDI	IVD General	Active
A21 Series 2000 CE	2000-0031	EUDAMED	IVD General	Active
VALIDATE® GC2 Test Set	1200bc	EUDAMEDFDA UDI	IVD General	Active
A106 HIV-1 Ag	2015-0065	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC2 Test Set	1200re	EUDAMEDFDA UDI	IVD General	Active
ACCURUN Anti-SARS-CoV-2 Series 1000	2015-0222	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC2 Test Set	1200sa	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® VITAMIN D Test Set	506vt	EUDAMEDFDA UDI	IVD General	Active
Accurun 1 Series 5100 positive control	2000-0016	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC1 Test Set	1100bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC1 Test Set	701vt	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC1 Test Set	1100sd	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® HEPARIN Test Set	903se	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® HEPARIN Test Set	903st	EUDAMEDFDA UDI	IVD General	Active
Multichem ID Multi-Marker Negative Control 2 x 4mL	2010-0260	EUDAMEDFDA UDI	Class B	Active
ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100	2025-0067	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® UC5 Test Set	705db	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® SP1 Test Set	601ro	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000	2015-0093	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® PTH Test Set	303ro	EUDAMEDFDA UDI	IVD General	Active
ACCURUN Babesia Molecular Controls Kit	2020-0155	EUDAMEDFDA UDI	Class B	Active
ACCURUN 146 CMV IgM Positive Control	2015-0088	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® GC3 Test Set	1300au	EUDAMEDFDA UDI	IVD General	Active
ACCURUN Anti-SARS-CoV-2 Series 2000	2015-0225	EUDAMEDFDA UDI	IVD General	Active
Control Kit - GC1ab L5	92-001001-00	EUDAMED	IVD General	Active
VALIDATE® GC4 Test Set	1400sa	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® VITAMIN D Test Set	506	EUDAMEDFDA UDI	IVD General	Active
Accurun 1 S8100 Positive Control	2000-0022	EUDAMEDFDA UDI	IVD General	Active

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