LGC Clinical Diagnostics, Inc.

FDA Device Registration & Listing · Gaithersburg, MD, US · Registration 3003610890

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003610890
FEI Number
3003610890
Entity Name
LGC Clinical Diagnostics, Inc.
City/State/Country
Gaithersburg, MD, US
Establishment Address
910 Clopper road, Gaithersburg, MD 20878, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
LGC Clinical Diagnostics, Inc. (Owner Number: 9041170)
Owner / Operator Contact Address
37 Birch Street, --, Milford, MA 01757, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

VALIDATE PRO-C3 Calibration Verification/Linearity Test Kit, product code:609re ACCURUN BKV DNA Positive Control VALIDATE pTau217 Plasma Calibration Verification/Linearity Test Kit, product code:807re ACCURUN EBV DNA Positive Control VALIDATE Fibrinogen Calibration Verification/Linearity Test Kit, product code: 904il, 904se, 904st VALIDATE D-Dimer Calibration Verification/Linearity Test Kit, product code: 902il, 902se, 902st Accuplex SARS-COV-2 Full genome VALIDATE HS Troponin Calibration Verification/Linearity Test Kit, product code:405ab VALIDATE Ferritin Calibration Verification/Linearity Test Kit, product code:307 VALIDATE Whole Blood Glucose Calibration Verification/Linearity Test Kit, product code:607ro VALIDATE Procalcitonin Calibration Verification/Linearity Test Kit, product code:403ab, 403ro NTproBNP Install Kit C-1001RO ACCURUN Anti-SARS-CoV-2 IgM Controls Kit VALIDATE HbA1c Calibration Verification/Linearity Test Kit, product code:605, 605sa, 605to ACCURUN Anti-SARS-CoV-2 ACCURUN Cytomegalovirus (CMV) Positive Molecular Control VALIDATE Folate RBC Calibration Verification/Linearity Test Kit, product code 309re VALIDATE Anti-CCP (210RE) VALIDATE THY2 Hormone Calibration Verification/Linearity Test Kit, product code:908ro VALIDATE IL-6 Calibration Verification/Linearity Test Kit, product code:509ro AccuTrak sFlt-1 Calibration Verification Panel VALIDATE OCN Calibration Verification/Linearity Test Kit, product code:305re VALIDATE PTH Calibration Verification/Linearity Test Kit, product code:303ro VALIDATE Rubella IgG Calibration Verification/Linearity Test Kit, product code: 802re AccuTrak aTG Calibration Verification Panel, product code: 2400-0253 VALIDATE Growth Hormone 2 Calibration Verification/Linearity Test Kit, product code: 511ro VALIDATE VIT D Calibration Verification/Linearity Test Kit, product code: 506ro AccuPlex HEV RNA control VALIDATE Toxo IgG Calibration Verification/Linearity Test Kit, product code: 803re VALIDATE pTau181 CSF Calibration Verification/Linearity Test Kit, product code:804re AccuTrak aTSHR Calibration Verification Panel, product code: 2400-0255 VALIDATE PTau181 Plasma Calibration Verification/Linearity Test Kit, product code:806re VALIDATE Hepatitis B Surface IgG Antibody (aHBs) Calibration Verification/Linearity Test Kit, product code:801mm VALIDATE Anti-SARS-CoV2 IgG Calibration Verification/Linearity Test Kit, product code: 510mm VALIDATE CT Calibration Verification/Linearity Test Kit, product code:907re FT4 Install Kit C-1002RO VALIDATE ACTH Calibration Verification/Linearity Test Kit, product code:302mm VALIDATE Fertility 4 Calibration Verification/Linearity Test Kit, product code: 305re VALIDATE® PSA Calibration Verification/Linearity Test Kit, product code: 406ab AccuTrak T-Uptake Calibration Verification Panel, product code:2400-0259 AccuTrak Abeta42 Calibration Verification Panel, product code: 2400-0258 VALIDATE Methotrexate Calibration Verification/Linearity Test Kit, product code:310ro VALIDATE Anti-HEV Calibration Verification/Linearity Test Kit, product code:808re VALIDATE B-CTx Calibration Verification/Linearity Test Kit, product code: 304re AccuTrak aTPO Calibration Verification Panel, product code: 2400-0254 VALIDATE HS Troponin Calibration Verification/Linearity Test Kit, product code:405re VALIDATE tTau CSF Calibration Verification/Linearity Test Kit, product code:805re VALIDATE Heparin Calibration Verification/Linearity Test Kit, product code: 903il, 903se, 903st ACCURUN 25 ToRCH IgG Positive Control S5000 ACCURUN 26 ToRC IgM Positive Control Series 5000 ACCURUN 25 Torch IgG Positive Control Series 1000 MultiChem ID TORC IgM Positive Control MultiChem ID ToRCH Negative Control MultiChem ID Rubella IgM Positive Control MultiChem ID TORCH IgG Positive Control ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 2000 ACCURUN 52 Multi-Marker Hepatitis Positive Control 2 S3000 ACCURUN 125 Anti-HBs Positive Control ACCURUN 141 Rubella IgM Positive Control ACCURUN 378 HPV DNA Positive Control Series 5000 ACCURUN 31 EBV IgM Positive Control ACCURUN 841 CT/NG Negative Control ACCURUN 136 Toxoplasma IgM Positive Control ACCURUN 872 HPV DNA Negative Control ACCURUN 372 HPV DNA Positive Control Series 400 Multichem ID Multi-Marker Negative Control ACCURUN 156 Reagin (Syphilis) Positive Control ACCURUN 52 Multi-Marker Hepatitis Positive Control 2 ACCURUN 127 Anti-Hepatitis Delta Positive Control ACCURUN 190 Chagas Positive Control ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 ACCURUN 115 Hepatitis B Core IgG Positive Control AccuPlex rEbola GP/NP Reference Material (0505-0001) ACCURUN 113 HBc IgM Positive Control ACCURUN 30 EBV IgG Positive Control ACCURUN 501 C. difficile Control ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 ACCURUN 372 HPV DNA Positive Control Series 600 ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700 ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control ACCURUN 810 Multi-Marker Negative Control ACCURUN 810 Series 2700 Multi Marker Negative Control Validate Fertility 1 unassayed calibration verification/linearity test kit Product Code 502re ACCURUN® 132 Lyme IgM Positive Control Validate SP2 unassayed calibration verification/linearity test kit, Product code 602re Validate Ferritin unassayed calibration verification/linearity test solution, Product code 307 ACCURUN® 120 HAV IgG Positive Control Multichem ID MM Neg 4 x 5mL Multichem ID Hepatitis 2 Positive Control ACCURUN 6 Multi Marker Positive Control ACCURUN® 121 HAV IgM Positive Control Accurun Babesia Molecular Positive Control Kit ACCURUN 2 Series 5600 ACCURUN 51 S2700 ACCURUN 810 S2700 Validate whole blood glucose unassayed calibration verification/linearity test kit, product code 607 ACCURUN 5 Multi Marker Positive Control ACCURUN 3 Multi Marker Positive Control ACCURUN TV/MG Positive Molecular Control Kit Validate SP2 unassayed calibration verification/linearity test kit, Product code 602bc Validate Tumor Markers unassayed calibration verification/linearity test kit, Product code 407sa MCID Multi-Marker Negative Control ACCURUN® 130 Lyme IgG Positive Control Validate Fertility 2 unassayed calibration verification/linearity test kit Product Code 504re Validate Heparin se calibration verification /linearity kit, product code 903se Validate HbA1c unassayed calibration verification/linearity test kit, Product Code 605 Validate Tumor Markers unassayed calibration verification/linearity test kit, Product code 407 AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit (0505-0260) Validate SP2 unassayed calibration verification/linearity test solution, Product code 602 ACCURUN MRSA/MSSA Positive Molecular Control Multichem ID MM HEP1 Pos 4 x 5mL ACCURUN 4 Multi-Marker Positive Control AccuPlex Viral Fever-ELCM Multichem ID HAV IgM Positive Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2020-06-29
DGQ Whole Blood Plasma, Antigen, Antiserum, Control Immunology Class 1 866.5700 2016-10-14
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2015-08-18

Official Correspondent

David Larrivee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LGC Clinical Diagnostics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1226774 LGC Clinical Diagnostics, Inc. Cumberland Foreside, ME, US
3007088335 LGC Clinical Diagnostics, Inc. Milford, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003610890. Last updated year: 2026. Please use registration number 3003610890 when referencing this establishment in official correspondence.
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