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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 5 of 7

Device	Model / Reference	Registries	Class	Status
ACCURUN 315 HIV-1 RNA Positive Quality Control Series 500	2020-0093	EUDAMEDFDA UDI	IVD General	Active
Multichem ID ToRCH IgG Negative Control	2010-0023	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® GC3 Test Set	1300wa	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® THY Test Set	901bc	EUDAMEDFDA UDI	IVD General	Active
Multichem ID HAV IgM Positive Control	2015-0337	EUDAMEDFDA UDI	Class B	Active
VALIDATE® HS Troponin Test Set	405ro	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 141 Rubella IgM Positive Control	2015-0086	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® LP Test Set	501ab	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000	2015-0092	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC1 Test Set	1100sa	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 305 Series 400 HCV RNA	2020-0085	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FERTILITY 2 Test Set	504re	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC3 Test Set	1300bcc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC1 Test Set	1100sv	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® D-DIMER Test Set	902se	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC1 Test Set	701ri	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® TDM1 Test Set	301db	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 120 Anti-HAV IgG	2015-0073	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700	2025-0068	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® IBC Test Set	203vt	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® IBC Test Set	203sd	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FERTILITY 2 Test Set	504ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® BODY FLUIDS 2 Test Set	206ro	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 25 ToRCH IgG Positive Control S5000	2000-0034	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® GC4 Test Set	1400ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FERTILITY 1 Test Set	502ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC4 Test Set	1400sd	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC1 Test Set	701sa	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® SP2 Test Set	602bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® ACTH Test Set	302mm	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® SP1 Test Set	601bcs	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 305 Series 100 HCV RNA	2020-0080	EUDAMEDFDA UDI	IVD General	Active
A1 Series 2500	2000-0002	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FIBRINOGEN Test Set	904il	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 372 HPV DNA Positive Control Series 600	2025-0041	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 315 Series 200 HIV-1 RNA	2020-0090	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® TUMOR MARKERS Test Set	407sa	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® TUMOR MARKERS Test Set	407re	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® HS Troponin Test Set	405ab	EUDAMEDFDA UDI	IVD General	Active
A325 Series 200 HBV DNA	2020-0096	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CHEM 4 Test Set	104ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® Whole Blood Glucose Test Set	607ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC3 Test Set	1300ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® HEPARIN Test Set	903il	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC4 Test Set	1400au	EUDAMEDFDA UDI	IVD General	Active
A106 HIV-1 Ag	2015-0066	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 125 Anti-HBs Positive Control	2015-0077	EUDAMEDFDA UDI	IVD General	Active
A1 Negative Control	2010-0015	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 315 Series 400 HIV-1 RNA	2020-0092	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC1 Test Set	1100ri	EUDAMEDFDA UDI	IVD General	Active

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