FDA Registration
Active
🇺🇸 United States
LGC Clinical Diagnostics, Inc.
Reg #: 3007088335
·
FEI: 1220394
·
Expires 2026
Products
9
Proprietary Names
186
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- LGC Clinical Diagnostics, Inc.
- Registration Number
- 3007088335
- FEI Number
- 1220394
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 37 Birch St
- City
- Milford
- State
- MA
- ZIP
- 01757
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK970004
Owner / Operator
- Firm Name
- LGC Clinical Diagnostics, Inc.
- Operator Number
- 9041170
- Address
- 37 Birch Street, --
- City
- Milford
- State
- MA
- Postal Code
- 01757
- Country
- US
- Correspondent
- David - Larrivee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Quality Control For Blood Banking Reagents | KSF | Class 2 | Hematology | No | 2016-09-22 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2015-08-18 |
| Whole Blood Plasma, Antigen, Antiserum, Control | DGQ | Class 1 | Immunology | No | 2016-10-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-09-22 |
| Kit, Test (Donors), For Bloodborne Pathogen | MYZ | Class 2 | Unknown | No | 2006-12-28 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2018-09-24 |
| Kit, Serological, Positive Control | MJX | Class 1 | Clinical Chemistry | No | 2007-12-06 |
| Antibody Igm,If, Cytomegalovirus Virus | LKQ | Class 2 | Microbiology | No | 2007-12-06 |
| Antisera, If, Toxoplasma Gondii | LJK | Class 2 | Microbiology | No | 2007-12-06 |
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
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
ACCURUN 117 HBEAG POSITIVE CONTROL
ACCURUN 305 HCV RNA Positive Control, Series 400
ACCURUN 305 HCV RNA Positive Control, Series 300
ACCURUN 305 HCV RNA Positive Control, Series 100
ACCURUN 305 HCV RNA Positive Control, Series 150
Establishment Types
Manufacture Medical Device