LGC Clinical Diagnostics, Inc.

FDA Device Registration & Listing · Cumberland Foreside, ME, US · Registration 1226774

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
1226774
FEI Number
3003407015
Entity Name
LGC Clinical Diagnostics, Inc.
City/State/Country
Cumberland Foreside, ME, US
Establishment Address
221 US Route 1, Cumberland Foreside, ME 04110, 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
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 VALIDATE SP3 Calibration Verification/Linearity Test Kit, product code: 603ab KOVA-Trol III Normal with hCG, product codes: 87331, 87327, 87528 VALIDATE® LCMS ISx Calibration Verification/Linearity Test Kit, product code: 1004ro VALIDATE® LCMS TDM Calibration Verification/Linearity Test Kit, product code: 1002ro VALIDATE Diabetes Calibration Verification/Linearity Test Kit, product code: 204ro VALIDATE CM3 Calibration verification/linearity test kit, product code: 409ro VALIDATE Body Fluids 3 Calibration Verification/Linearity Test Kit, product code: 207ro VALIDATE Fertility 2 Calibration Verification/Linearity Test Kit, product code: 504ab, 504re VALIDATE CM1 Calibration verification/linearity test kit, product code: 401ro VALIDATE Body Fluids 2 Calibration Verification/Linearity Test Kit, product code: 206ro VALIDATE Anemia Calibration verification/linearity test kit, product codes: 308ab, 308bc, 308re, 308vt VALIDATE UC4 Calibration Verification/Linearity Test Kit, product code: 704ab, 704sa VALIDATE GC3 Calibration verification/linearity test kit, product codes: 1300wa VALIDATE Fertility 1 Calibration Verification/Linearity Test Kit, product code: 502ab, 502re VALIDATE SP2 Calibration verification/linearity test kit, product codes: 602bc, 602re VALIDATE Fertility 3 Calibration Verification/Linearity Test Kit, product code: 505ro VALIDATE LCMS Steroids Calibration Verification/Linearity Test Kit, product code: 1003ro VALIDATE SP1 Calibration Verification/Linearity Test Kit, product code: 601ro VALIDATE® LCMS VIT D Calibration Verification/Linearity Test Kit, product code: 1001ro VALIDATE Tumor Markers 2 Calibration Verification/Linearity Test Kit, product code: 408re VALIDATE THY Calibration verification/linearity test kit, product codes: 901ab VALIDATE GC1 Calibration verification/linearity test kit, product codes: 1100wa VALIDATE LP2 Calibration Verification/Linearity Test Kit, product code: 507ro VALIDATE IBC Calibration Verification/Linearity Test Kit, product codes: 203ro, 203sd, 203vt VALIDATE UC1 Calibration Verification/Linearity Test Kit, product code: 701ab, 701re, 701sa VALIDATE UC5 Calibration Verification/Linearity Test Kit, product code: 705ab VALIDATE® CM2 Calibration Verification / Linearity Test Set (Product Code 402pf) VALIDATE ISx Calibration Verification/Linearity Test Kit, product code: 608mm VALIDATE High Sensitive Troponin Calibration Verification/Linearity Test Kit, product code 405ro VALIDATE SP3 Calibration verification/linearity test kit, product code: 603ro VALIDATE Tumor Markers Calibration Verification/Linearity Test Kit, product codes: 407ab, 407re, 407sa VALIDATE Body Fluids Calibration Verification/Linearity Test Kit, product codes: 205bf, 205ro VALIDATE THY2 Hormone Calibration Verification/Linearity Test Kit, product code:908bc KOVA-Trol II Low Abnormal, product code: 87130 KOVA-Trol I High Abnormal with Urobilinogen Value Assignment, product codes: 87533, 87332, 87334 VALIDATE TDM1 Calibration verification/linearity test kit, product codes: 301ab, 301au, 301bc, 301db, 301ri, 301vt VALIDATE Growth Hormone Calibration Verification/Linearity Test Kit, product code: 508ro VALIDATE SP2 Calibration Verification/Linearity Test Kit, product code: 602ab THY Calibration Verification Test S Validate THY product code 901re Validate THY product code 901bc VALIDATE Thyroid Calibration Verification Test Set VALIDATE SP1 Calibration Verification Test Set (601bc, 601bcs) SP1 Calibration Verification Test Set VALIDATE UC4 Urine Chemistry Verification Test Set VALIDATE UC5 Urine Chemistry Verification Test Set VALIDATE Urine Chemistry Calibration Verification Test Set VALIDATE OSMO Urine Chemistry Verification Test Set VALIDATE UC1 Urine Chemistry Verification Test Set UC5 product codes 705au, 705bcc, 705db, 705ri, 705ro, 705vt OSMO product code 703 UC4 product codes 704au, 704bc, 704db, 704ri, 704ro UC6 product code 706af VALIDATE UC6 Urine Chemistry Verification Test Set UC1 product codes 701au, 701bc, 701db, 701ri, 701ro, 701vt Validate GC2 product codes: 1200ab, 1200au, 1200bc, 1200re, 1200sa, 1200sd, 1200vt Validate GC1, GC2, GC3 and GC4 Cali Validate GC3 product codes: 1300ab, 1300au, 1300bcc, 1300re, 1300sa, 1300sd, 1300vt Validate GC1 product codes:1100ab, 1100au, 1100bc, 1100ri, 1100ro, 1100sa, 1100sd, 1100sv, 1100vt Validate GC4 product codes: 1400ab, 1400au, 1400bc, 1400re, 1400ri, 1400sa, 1400sd, 1400vt Validate hsCRP Calibration Verification Linearity Test Kit product code 404ro VALIDATE CM2 Calibration Verification/Linearity Test Set Validate CM2vt Calibration Verification Linearity Test Kit, product code 402vt Validate CM2 product code 402re Validate CM2 product code 402bc Validate CM2 product code 402ab CM2 Calibration Verification/Linear VALIDATE Lipoprotein 1 Calibration Verification Test Set LP product codes 501ab, 501au, 501bc, 501db, 501ro, 501sa, 501vt Lipoprotein 1 Calibration Verification Test Set VALIDATE Chem 2 Calibration Verification Test Set MSC Chem 4 Calibration Verification Test Set Validate Chem 4 product code 104ab Validate CM1 product code 401ab Validate CM1 product code 401db Validate CM1 product code 401bc VALIDATE Cardiac Marker Calibration Verification Test Set

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
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-09-17
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-18
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-30

Official Correspondent

No official correspondent registered.

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
3003610890 LGC Clinical Diagnostics, Inc. Gaithersburg, MD, 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 1226774. Last updated year: 2026. Please use registration number 1226774 when referencing this establishment in official correspondence.
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