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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 6 of 7

Device	Model / Reference	Registries	Class	Status
A810 Negative Control	2010-0020	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FERRITIN Test Set	307	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® PROCALCITONIN Test Set	403ro	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 26 ToRC IgM Positive Control Series 5000	2000-0035	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® BODY FLUIDS 3 Test Set	207RO	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC4 Test Set	704sa	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 372 HPV DNA Positive Control Series 400	2025-0037	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC4 Test Set	704au	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CM1 Test Set	401ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CM2 Test Set	402ab	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 156 Reagin (Syphilis) Positive Control	2015-0094	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CM2 Test Set	402bc	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 305 Series 150 HCV RNA Positive Control	2020-0078	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 25 ToRCH IgG Positive Control S2000	2000-0074	EUDAMED	IVD Annex II List B	Active
ACCURUN 130 Borrelia burgdorferi IgG Positive Control	2015-0080	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 31 EBV IgM Positive Control	2000-0038	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 132 Borrelia burgdorferi IgM Positive Control	2015-0081	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® SP2 Test Set	602re	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® LP Test Set	501au	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC5 Test Set	705ri	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® D-DIMER Test Set	902st	EUDAMEDFDA UDI	IVD General	Active
A1 Series 4000	2000-0008	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® ANEMIA Test Set	308ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC5 Test Set	705ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® TDM1 Test Set	301ab	EUDAMEDFDA UDI	IVD General	Active
A115 Anti-HBc IgG	2015-0070	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® TUMOR MARKERS Test Set	407ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC4 Test Set	704db	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC1 Test Set	701ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC4 Test Set	1400re	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC4 Test Set	1400bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® SP3 Test Set	603ro	EUDAMEDFDA UDI	IVD General	Active
Control Kit - PHOS L1	92-201353-00	EUDAMED	IVD General	Active
A21 Series 1000 CE	2000-0028	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® TDM1 Test Set	301ri	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® IL-6 Test Set	509ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® OSMO Test Set	703	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® LP Test Set	501ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC3 Test Set	1300sd	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® LP Test Set	501db	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 145 CMV IgG Positive Control	2015-0087	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® ANEMIA Test Set	308re	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC4 Test Set	704ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC4 Test Set	704ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® HbA1c Test Set	605sa	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC4 Test Set	1400ri	EUDAMEDFDA UDI	IVD General	Active
Control Kit - GC3ab L5-L6	92-001002-00	EUDAMED	IVD General	Active
VALIDATE® CM3 Test Set	409ro	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® LP Test Set	501bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC3 Test Set	1300sa	EUDAMEDFDA UDI	IVD General	Active

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