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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 4 of 7

Device	Model / Reference	Registries	Class	Status
Centria T4 Ria	K761272	FDA 510(k)	Class II	Active
Centrifichem Sys 400 Analyzer	K771813	FDA 510(k)	Class I	Active
Gordon Diagnostic System Model I	K854903	FDA 510(k)	U	Active
Glucochek	K940215	FDA 510(k)	Class II	Active
Glucochek Pocketlab Ii Blood Glucose System	K971653	FDA 510(k)	Class II	Active
Centria Cortisol Ria	K771117	FDA 510(k)	Class II	Active
Glucochek Pocketlab	K951457	FDA 510(k)	Class II	Active
Centria Separation Columns Type A	K771118	FDA 510(k)	Class II	Active
ACCURUN 140 Rubella IgG Positive Control	2015-0084	EUDAMEDFDA UDI	IVD Annex II List B	Active
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150	2020-0105	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000	2000-0062	EUDAMED	IVD General	Active
VALIDATE® TDM1 Test Set	301au	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC1 Test Set	1100wa	EUDAMEDFDA UDI	IVD General	Active
A127 Anti-Delta	2015-0079	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 501 C. difficile Control	2050-0008	EUDAMED	IVD General	Active
VALIDATE® GC2 Test Set	1200sd	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 305 Series 300 HCV RNA	2020-0083	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® CM1 Test Set	401bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC5 Test Set	705vt	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC2 Test Set	1200vt	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000	2000-0039	EUDAMEDFDA UDI	IVD Annex II List B	Active
VALIDATE® FERTILITY 1 Test Se	502re	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 315 Series 150 HIV-1 RNA	2020-0087	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® IBC Test Set	203ro	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150	2020-0104	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC1 Test Set	701bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® GC3 Test Set	1300vt	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® SP1 Test Set	601bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC5 Test Set	705bcc	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000	2000-0067	EUDAMED	IVD General	Active
VALIDATE® GC1 Test Set	1100vt	EUDAMEDFDA UDI	IVD General	Active
Accurun 2 Series 2700	2000-0024	EUDAMED	IVD General	Active
Accurun 2 Series 2700	2000-0023	EUDAMED	IVD General	Active
ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000	2015-0090	EUDAMEDFDA UDI	IVD General	Active
A325 Series 700 HBV DNA	2020-0098	EUDAMEDFDA UDI	IVD General	Active
A52 Hepatitis Multi-Marker	2000-0043	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 873 HPV DNA Negative Control	2035-0005	EUDAMEDFDA UDI	IVD General	Active
A1 Series 5600	2000-0018	EUDAMEDFDA UDI	IVD General	Active
A51 Hepatitis Multi-Marker	2000-0041	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control	2015-0072	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® HbA1c Test Set	605to	EUDAMEDFDA UDI	IVD General	Active
ACCURUN 190 Chagas Positive Control	2015-0097	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC5 Test Set	705ab	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® FIBRINOGEN Test Set	904se	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® ANEMIA Test Set	308bc	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® UC1 Test Set	701db	EUDAMEDFDA UDI	IVD General	Active
Validate	801mm	EUDAMEDFDA UDI	Class B	Active
VALIDATE® ANEMIA Test Set	308vt	EUDAMEDFDA UDI	IVD General	Active
A113 Anti-HBc IgM	2015-0068	EUDAMEDFDA UDI	IVD General	Active
VALIDATE® LP Test Set	501sa	EUDAMEDFDA UDI	IVD General	Active

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