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Sign in to claim this brandLGC 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
- —
- —
- [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 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Optitrol NAT HBV Screening, 10x 1, 2 mL | NT01012 | EUDAMED | Class B | Active |
| Optitrol Paediatric G-2, 2x pos, 2, 5mL | SR15027 | EUDAMED | Class B | Active |
| Optitrol Chagas-1, 1x pos, 1mL | SR16025 | EUDAMED | Class B | Active |
| Optitrol Yellow, 1x pos, 1mL | SR11029 | EUDAMED | Class B | Active |
| Optitrol Red, 1x pos, 1mL | SR11059 | EUDAMED | Class B | Active |
| Optitrol NAT HCV Screening, 10x 1, 2 mL | NT01022 | EUDAMED | Class B | Active |
| Optitrol HIV p24, 4x pos, 2.5mL | SR11103 | EUDAMED | Class B | Active |
| Optitrol HEPR-2, 2x pos, 2.5mL | SR12057 | EUDAMED | Class B | Active |
| Optitrol HIV 2, 2x pos, 2.5mL | SR11117 | EUDAMED | Class B | Active |
| Optitrol NAT NEG, 5x 1, 2 mL | NT01051 | EUDAMED | Class B | Active |
| Optitrol NAT NEG, 10x 1, 2 mL | NT01052 | EUDAMED | Class B | Active |
| Optitrol SeroNeg, 4x neg, 1mL | SR11000 | EUDAMED | Class B | Active |
| Optitrol Orange, 2x pos, 5mL | SR11063 | EUDAMED | Class B | Active |
| Optitrol Orange, 4x pos, 5mL | SR11061 | EUDAMED | Class B | Active |
| Optitrol NAT Triplex, 10x 1, 2 mL | NT01042 | EUDAMED | Class B | Active |
| Optitrol Yellow, 2x pos, 5mL | SR11023 | EUDAMED | Class B | Active |
| Optitrol Mumps M, 1x pos, 1mL | SR15065 | EUDAMED | Class B | Active |
| Optitrol NAT HIV Screening, 10x 1, 2 mL | NT01032 | EUDAMED | Class B | Active |
| Optitrol Chagas-1, 2x pos, 2.5mL | SR16027 | EUDAMED | Class B | Active |
| Optitrol Paediatric G negative, 2x neg, 2, 5mL | SR15006 | EUDAMED | Class B | Active |
| Optitrol HEPA-1, 1x pos, 1mL | SR12025 | EUDAMED | Class B | Active |
| Optitrol Paediatric G-2, 1x pos, 1mL | SR15025 | EUDAMED | Class B | Active |
| Optitrol HIV 2, 1x pos, 1mL | SR11115 | EUDAMED | Class B | Active |
| Optitrol Blue | SR11011 | EUDAMED | Class B | Active |
| Optitrol Mumps M, 2x pos, 1mL | SR15068 | EUDAMED | Class B | Active |
| Optitrol NAT HBV Screening, 5x 1, 2 mL | NT01011 | EUDAMED | Class B | Active |
| Optitrol Orange, 1x pos, 1mL | SR11069 | EUDAMED | Class B | Active |
| Optitrol Blue | SR11013 | EUDAMED | Class B | Active |
| Optitrol HEPA-1, 2x pos, 2.5mL | SR12027 | EUDAMED | Class B | Active |
| Optitrol NAT Parvo B19, 5x 1.2 mL | NT05021 | EUDAMED | Class B | Active |
| Optitrol NAT HIV-2, 5x 1, 2 mL | NT01035 | EUDAMED | Class B | Active |
| Optitrol SeroNeg, 2x neg, 1mL | SR11001 | EUDAMED | Class B | Active |
| Optitrol NAT Parvo B19, 10x 1, 2 mL | NT05022 | EUDAMED | Class B | Active |
| Optitrol Chagas-2, 1x pos, 1mL | SR16035 | EUDAMED | Class B | Active |
| Optitrol HEPA-2, 1x pos, 1mL | SR12035 | EUDAMED | Class B | Active |
| Optitrol Blue | SR11019 | EUDAMED | Class B | Active |
| Optitrol NAT HIV-2, 10x 1, 2 mL | NT01036 | EUDAMED | Class B | Active |
| Optitrol NAT Triplex, 5x 1, 2 mL | NT01041 | EUDAMED | Class B | Active |
| Optitrol HEPR-2, 1x pos, 1mL | SR12055 | EUDAMED | Class B | Active |
| Optitrol Red, 2x pos, 5mL | SR11053 | EUDAMED | Class B | Active |
| Optitrol Red, 4x pos, 5mL | SR11051 | EUDAMED | Class B | Active |
| Optitrol HEPA-2, 2x pos, 2.5mL | SR12037 | EUDAMED | Class B | Active |
| Optitrol Yellow 4x5 mL | SR11021 | EUDAMED | Class B | Active |
| Optitrol HIV p24, 4x pos, 5mL | SR11101 | EUDAMED | Class B | Active |
| Optitrol HIV p24, 2x pos, 2.5mL | SR11107 | EUDAMED | Class B | Active |
| Accurun® | 2000-0032 | FDA UDI | Class II | Active |
| FT4 Install Kit | C-1002ro | FDA UDI | Class I | Active |
| NTproBNP Install Kit | C-1001ro | FDA UDI | Class I | Active |
| Validate | 204ro | FDA UDI | Class I | Active |
| ACCURUN® 2 Series 5600 | 2000-0100 | FDA UDI | Class I | Active |
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