Manufacturer's Devices - Microgenics Corporation

Address:




46500 Kato Road



Fremont CA USA

Ca 94538

United States

Serilization:


Authorised Representative
Name: Life Technologies Ltd
Address:

3 Fountain Drive Inchinnan Business Park



Paisley

Renfrewshire PA4 9RF

United Kingdom




Code/Term Type
Hepatitis B virus antigen/antibody marker IVD, controlIVD Annex II List A
Hepatitis C virus antibody/antigen IVD, controlIVD Annex II List A
HIV1 nucleic acid IVD, controlIVD Annex II List A
Multiple-type sexually transmitted pathogen nucleic acid IVD, controlIVD Annex II List A
PCR/NAT negative control IVDIVD Annex II List A
Multiple tissue-associated protein/tumour marker IVD, controlIVD Annex II List B
Multiple-type clinical chemistry analyte profile IVD, controlIVD Annex II List B
Total bilirubin IVD, controlIVD Annex II List B
Multiple urine analyte IVD, controlIVD General
Multiple therapeutic drugs/drugs of abuse IVD, controlIVD General
Treponema pallidum total antibody IVD, controlIVD General
C-reactive protein (CRP) IVD, controlIVD General
Parathyroid hormone (PTH) IVD, controlIVD General
Buprenorphine IVD, calibratorIVD General
Buprenorphine IVD, kit, enzyme immunoassay (EIA)IVD General
Buprenorphine IVD, controlIVD General
Glycated haemoglobin (HbA1c) IVD, controlIVD General
Creatinine IVD, controlIVD General
Creatinine IVD, calibratorIVD General
Acetaminophen IVD, calibratorIVD General
Amikacin therapeutic drug monitoring IVD, calibratorIVD General
Multiple cardiac marker IVD, controlIVD General
Enterovirus nucleic acid (serotypes 68-71) IVD, controlIVD General
West Nile virus nucleic acid IVD, controlIVD General
Epstein-Barr virus (EBV) nucleic acid IVD, controlIVD General
BK virus (BKV) antigen IVD, controlIVD General
MRSA nucleic acid IVD, controlIVD General
Creatinine IVD, kit, spectrophotometryIVD General
Troponin T/Troponin I IVD, controlIVD General
Urine pH IVD, kit, colorimetric dipstick, rapidIVD General
Multiple-therapy therapeutic drug monitoring IVD, calibratorIVD General
Multiple-therapy therapeutic drug monitoring IVD, controlIVD General
Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Gentamicin therapeutic drug monitoring IVD, calibratorIVD General
Tobramycin therapeutic drug monitoring IVD, calibratorIVD General
Vancomycin therapeutic drug monitoring IVD, calibratorIVD General
Teicoplanin therapeutic drug monitoring IVD, calibratorIVD General
Teicoplanin therapeutic drug monitoring IVD, controlIVD General
Teicoplanin therapeutic drug monitoring IVD, reagentIVD General
Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Digitoxin therapeutic drug monitoring IVD, kit, fluorescent immunoassayIVD General
N-acetylprocainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Quinidine therapeutic drug monitoring IVD, calibratorIVD General
Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Zonisamide therapeutic drug monitoring IVD, kit, fluorescent immunoassayIVD General
Zonisamide therapeutic drug monitoring IVD, calibratorIVD General
Zonisamide therapeutic drug monitoring IVD, controlIVD General
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassayIVD General
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibratorIVD General
Tacrolimus therapeutic drug monitoring IVD, calibratorIVD General
Tacrolimus therapeutic drug monitoring IVD, reagentIVD General
Mycophenolate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Mycophenolate therapeutic drug monitoring IVD, calibratorIVD General
Mycophenolate therapeutic drug monitoring IVD, controlIVD General
Multiple drugs of abuse IVD, calibratorIVD General
Multiple drugs of abuse IVD, controlIVD General
6-Acetyl morphine IVD, calibratorIVD General
6-Acetyl morphine IVD, reagentIVD General
Acetaminophen IVD, kit, enzyme immunoassay (EIA)IVD General
Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)IVD General
Amphetamine/methamphetamine group IVD, calibratorIVD General
Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)IVD General
Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)IVD General
Methamphetamine-specific IVD, calibratorIVD General
Methamphetamine-specific IVD, controlIVD General
Barbiturate IVD, kit, enzyme immunoassay (EIA)IVD General
Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)IVD General
Cannabinoid IVD, kit, enzyme immunoassay (EIA)IVD General
Cannabinoid IVD, calibratorIVD General
Cannabinoid IVD, controlIVD General
Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),IVD General
Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)IVD General
Cotinine (nicotine metabolite) IVD, calibratorIVD General
Cotinine (nicotine metabolite) IVD, controlIVD General
Ethanol (ETOH) IVD, kit, enzyme spectrophotometryIVD General
Ethanol (ETOH) IVD, calibratorIVD General
Ethanol (ETOH) IVD, controlIVD General
Fentanyl IVD, calibratorIVD General
Fentanyl IVD, controlIVD General
Fentanyl IVD, reagentIVD General
Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibratorIVD General
Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagentIVD General
Methadone IVD, kit, enzyme immunoassay (EIA)IVD General
Methaqualone IVD, kit, radioimmunoassayIVD General
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)IVD General
Opiate/opiate metabolite IVD, calibratorIVD General
Oxycodone IVD, calibratorIVD General
Oxycodone IVD, controlIVD General
Oxycodone IVD, reagentIVD General
Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)IVD General
Phenobarbital IVD, kit, enzyme immunoassay (EIA)IVD General
Propoxyphene IVD, kit, enzyme immunoassay (EIA)IVD General
Tricyclic antidepressant IVD, kit, fluorescent immunoassayIVD General
Negative control immunoglobulin IVDIVD General
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)IVD General
Total thyroxine (TT4) IVD, calibratorIVD General
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)IVD General
Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Drug/toxicology adulteration IVD, kit, spectrophotometryIVD General
Multiple immunosuppressant therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Multiple immunosuppressant therapeutic drug monitoring IVD, calibratorIVD General
Multiple immunosuppressant therapeutic drug monitoring IVD, controlIVD General
Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)IVD General
Ethyl glucuronide (EtG) IVD, calibratorIVD General
Ethyl glucuronide (EtG) IVD, controlIVD General
Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryIVD General
Topiramate therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryIVD General
Lamotrigine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryIVD General
Quinidine therapeutic?drug monitoring?IVD, kit,?nephelometry/turbidimetryIVD General
Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryIVD General
Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryIVD General
Vancomycin therapeutic?drug monitoring?IVD, kit,?nephelometry/turbidimetryIVD General
Tobramycin?therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)IVD General
Detergent solution IVDIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, controlIVD General
Digoxin therapeutic drug monitoring IVD, calibratorIVD General
Valproic?acid?therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryIVD General
Gentamicin?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayIVD General
Gentamicin?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayIVD General
Gentamicin?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayIVD General