LGC Clinical Diagnostics, Inc.

FDA Device Registration & Listing · Milford, MA, US · Registration 3007088335

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
3007088335
FEI Number
1220394
Entity Name
LGC Clinical Diagnostics, Inc.
City/State/Country
Milford, MA, US
Establishment Address
37 Birch St, Milford, MA 01757, 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

ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000 ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 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 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 ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV) ACCURUN 365 West Nile Virus RNA Positive Quality Control ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 ACCURUN 325 HBV DNA Positive Control Series 200 ACCURUN 325 HBV DNA Positive Control Series 700 ACCURUN 325 HBV DNA Positive Control Series 370 ACCURUN 140 RUBELLA IGG POSITIVE CONTROL ACCURUN 145 CMV IgG Positive Control ACCURUN 1 Multi-Marker Positive Control Series 4400 ACCURUN 1 Multi-Marker Positive Control Series 2400 ACCURUN 24 Multi-Marker Confirmatory Control ACCURUN 1 Multi-Marker Positive Control Series 2500 ACCURUN 1 Multi-Marker Positive Control Series 2700 ACCURUN 1 Multi-Marker Positive Control Series 4000 ACCURUN 1 Multi-Marker Positive Control Series 8100 ACCURUN 1 Multi-Marker Positive Control Series 5100 ACCURUN 1 Multi-Marker Positive Control Series 5600 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 106 HIV-1 Antigen ACCURUN 315 HIV-1 RNA Positive Quality Control, Series 150 ACCURUN 315 HIV-1 RNA Positive Quality Control, Series 400 ACCURUN 315 HIV-1 RNA Positive Quality Control, Series 200 ACCURUN 315 HIV-1 RNA Positive Quality Control, Series 500 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 Accurun 1 Multimarker Negative Control ACCURUN 146 CMV IGM POSITIVE CONTROL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2016-09-22
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2015-08-18
DGQ Whole Blood Plasma, Antigen, Antiserum, Control Immunology Class 1 866.5700 2016-10-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-09-22
MYZ Kit, Test (Donors), For Bloodborne Pathogen Unknown Class 2 N/A 2006-12-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2018-09-24
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-09-22
MJX Kit, Serological, Positive Control Clinical Chemistry Class 1 862.1660 2007-12-06
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2007-12-06
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2020-06-29
MYZ Kit, Test (Donors), For Bloodborne Pathogen Unknown Class 2 N/A 2016-10-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-09-22
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-09-17
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2016-09-22
LKQ Antibody Igm,If, Cytomegalovirus Virus Microbiology Class 2 866.3175 2007-12-06

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
3003610890 LGC Clinical Diagnostics, Inc. Gaithersburg, MD, US
1226774 LGC Clinical Diagnostics, Inc. Cumberland Foreside, ME, 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.

Similar Registrations

Registration Number Establishment Name Location
1000124057 GRIFOLS DIAGNOSTIC SOLUTIONS INC. Emeryville, CA, US
3011683976 ALBA BIOSCIENCE LIMITED PENICUIK Midlothian, GB
3010127294 Bio-Rad Laboratories Inc. Irvine, CA, US
3000308930 Ortho-Clinical Diagnostics European Support Center Illkirch, CEDEX Bas-Rhin, FR
1319681 ORTHO-CLINICAL DIAGNOSTICS, INC. Rochester, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007088335. Last updated year: 2026. Please use registration number 3007088335 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.