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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 7 of 7

Device	Model / Reference	Registries	Class	Status
A1 Series 2700	2000-0005	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® TDM1 Test Set	301vt	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® Immunosuppressants	608mm	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC5 Test Set	705au	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® BODY FLUIDS Test Set	205ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® PROCALCITONIN Test Set	403ab	EUDAMEDFDA UDI	IVD General	Active
A1 Series 4400	2000-0010	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 125 Anti-HBs Positive Control	2015-0078	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® VITAMIN D Test Set	506ab	EUDAMEDFDA UDI	IVD General	Active
ACCURUN Anti-SARS-CoV-2 IgM Controls Kit	2015-0232	EUDAMEDFDA UDI	IVD General	Active
ACCURUN117 Hepatitis B e Antigen Positive Control	2015-0071	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 136 Toxoplasma IgM Positive Control	2015-0083	EUDAMEDFDA UDI	IVD Annex II List B	Active
ACCURUN 841 CT/NG Negative Control	2025-0061	EUDAMEDFDA UDI	IVD Annex II List B	Active
ACCURUN 135 Toxoplasma IgG Positive Control	2015-0082	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® HbA1c Test Set	605	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 30 EBV IgG Positive Control	2000-0037	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC1 Test Set	1100au	EUDAMEDFDA UDI	IVD General	Active
A1 Series 2400	2000-0001	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC6 Test Set	706af	EUDAMEDFDA UDI	IVD General	Active
Multichem ID Rubella IgM Positive Control	2015-0240	EUDAMEDFDA UDI	IVD Annex II List B	Active
ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control	2025-0060	EUDAMEDFDA UDI	IVD General	Active
A1 Negative Control	2010-0013	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® LP2 Test Set	507ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FIBRINOGEN Test Set	904st	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC3 Test Set	1300re	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC4 Test Set	704bc	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 803 Nucleic Acid Negative Quality Control	2035-0007	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC4 Test Set	1400vt	EUDAMEDFDA UDI	IVD General	Active
A51 Hepatitis Multi-Marker	2000-0040	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 378 HPV DNA Positive Control Series 5000	2025-0043	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FERTILITY 3 Test Set	505ro	EUDAMEDFDA UDI	IVD General	Active
Multichem ID ToRCH IgG Positive Control	2000-0101	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® Anti-SARS-CoV2 IgG Test Set	510mm	EUDAMEDFDA UDI	IVD General	Active
Multichem ID ToRC IgM Positive Control	2000-0102	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® LP Test Set	501vt	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 121 HAV IgM Positive Control	2015-0074	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CHEM 17 Test Set	1700	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 800 ToRCH Negative Control	2010-0018	EUDAMEDFDA UDI	IVD Annex II List B	Active
ACCURUN 872 HPV DNA Negative Control	2035-0009	EUDAMEDFDA UDI	IVD General	Active

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