Manufacturer's Devices - Microgenics Corporation

Address:




46500 Kato Road



Fremont

California CA 94538

United States


Authorised Representative/ UK Responsible Person
Name: Thermo Fisher Diagnostics Ltd.
Address:

16 Shenley Pavillions Chalkdell Drive

Shenley Wood

Milton Keynes

MK5 6LB

England United Kingdom




Code/Term Type
Detergent solution IVDDetergent solution IVDClass A
Multiple-type clinical chemistry analyte profile IVD controlMultiple-type clinical chemistry analyte profile IVD controlIVD Annex II List B
Multiple-type sexually transmitted pathogen nucleic acid IVD controlMultiple-type sexually transmitted pathogen nucleic acid IVD controlIVD Annex II List B
Multiple tissue-associated protein/tumour marker IVD controlMultiple tissue-associated protein/tumour marker IVD controlIVD Annex II List B
Multiple urine analyte IVD controlMultiple urine analyte IVD controlIVD General
Total bilirubin IVD controlTotal bilirubin IVD controlIVD General
Multiple therapeutic drugs/drugs of abuse IVD controlMultiple therapeutic drugs/drugs of abuse IVD controlIVD General
Treponema pallidum total antibody IVD controlTreponema pallidum total antibody IVD controlIVD General
Parathyroid hormone (PTH) IVD controlParathyroid hormone (PTH) IVD controlIVD General
Buprenorphine IVD calibratorBuprenorphine IVD calibratorIVD General
Buprenorphine IVD kit enzyme immunoassay (EIA)Buprenorphine IVD kit enzyme immunoassay (EIA)IVD General
Buprenorphine IVD controlBuprenorphine IVD controlIVD General
Creatinine IVD controlCreatinine IVD controlIVD General
Creatinine IVD calibratorCreatinine IVD calibratorIVD General
Acetaminophen IVD calibratorAcetaminophen IVD calibratorIVD General
Amikacin therapeutic drug monitoring IVD calibratorAmikacin therapeutic drug monitoring IVD calibratorIVD General
Multiple cardiac marker IVD controlMultiple cardiac marker IVD controlIVD General
Multiple-type clinical chemistry analyte profile IVD controlMultiple-type clinical chemistry analyte profile IVD controlIVD General
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlIVD General
C-reactive protein (CRP) IVD controlC-reactive protein (CRP) IVD controlIVD General
West Nile virus nucleic acid IVD controlWest Nile virus nucleic acid IVD controlIVD General
Enterovirus nucleic acid (serotypes 68-71) IVD controlEnterovirus nucleic acid (serotypes 68-71) IVD controlIVD General
Epstein-Barr virus (EBV) nucleic acid IVD controlEpstein-Barr virus (EBV) nucleic acid IVD controlIVD General
BK virus (BKV) antigen IVD controlBK virus (BKV) antigen IVD controlIVD General
Creatinine IVD kit spectrophotometryCreatinine IVD kit spectrophotometryIVD General
Troponin T/Troponin I IVD controlTroponin T/Troponin I IVD controlIVD General
Urine pH IVD kit colorimetric dipstick rapidUrine pH IVD kit colorimetric dipstick rapidIVD General
Multiple-therapy therapeutic drug monitoring IVD controlMultiple-therapy therapeutic drug monitoring IVD controlIVD General
Gentamicin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Gentamicin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Leishmania species immunoglobulin G (IgG) antibody IVD reagentLeishmania species immunoglobulin G (IgG) antibody IVD reagentIVD General
Vancomycin therapeutic drug monitoring IVD calibratorVancomycin therapeutic drug monitoring IVD calibratorIVD General
Teicoplanin therapeutic drug monitoring IVD calibratorTeicoplanin therapeutic drug monitoring IVD calibratorIVD General
Teicoplanin therapeutic drug monitoring IVD controlTeicoplanin therapeutic drug monitoring IVD controlIVD General
Teicoplanin therapeutic drug monitoring IVD reagentTeicoplanin therapeutic drug monitoring IVD reagentIVD General
Digitoxin therapeutic drug monitoring IVD kit fluorescent immunoassayDigitoxin therapeutic drug monitoring IVD kit fluorescent immunoassayIVD General
N-acetylprocainamide therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)N-acetylprocainamide therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Procainamide therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Procainamide therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Phenytoin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Phenytoin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Zonisamide therapeutic drug monitoring IVD kit fluorescent immunoassayZonisamide therapeutic drug monitoring IVD kit fluorescent immunoassayIVD General
Zonisamide therapeutic drug monitoring IVD calibratorZonisamide therapeutic drug monitoring IVD calibratorIVD General
Zonisamide therapeutic drug monitoring IVD controlZonisamide therapeutic drug monitoring IVD controlIVD General
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD kit fluorescent immunoassayCyclosporin A/cyclosporine therapeutic drug monitoring IVD kit fluorescent immunoassayIVD General
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorCyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorIVD General
Tacrolimus therapeutic drug monitoring IVD calibratorTacrolimus therapeutic drug monitoring IVD calibratorIVD General
Tacrolimus therapeutic drug monitoring IVD reagentTacrolimus therapeutic drug monitoring IVD reagentIVD General
Mycophenolate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Mycophenolate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Mycophenolate therapeutic drug monitoring IVD calibratorMycophenolate therapeutic drug monitoring IVD calibratorIVD General
Mycophenolate therapeutic drug monitoring IVD controlMycophenolate therapeutic drug monitoring IVD controlIVD General
6-Acetyl morphine IVD calibrator6-Acetyl morphine IVD calibratorIVD General
6-Acetyl morphine IVD reagent6-Acetyl morphine IVD reagentIVD General
Acetaminophen IVD kit enzyme immunoassay (EIA)Acetaminophen IVD kit enzyme immunoassay (EIA)IVD General
Amphetamine/methamphetamine group IVD calibratorAmphetamine/methamphetamine group IVD calibratorIVD General
Amphetamine-specific IVD kit enzyme immunoassay (EIA)Amphetamine-specific IVD kit enzyme immunoassay (EIA)IVD General
Methamphetamine-specific IVD kit enzyme immunoassay (EIA)Methamphetamine-specific IVD kit enzyme immunoassay (EIA)IVD General
Methamphetamine-specific IVD calibratorMethamphetamine-specific IVD calibratorIVD General
Methamphetamine-specific IVD controlMethamphetamine-specific IVD controlIVD General
Cotinine (nicotine metabolite) IVD kit enzyme immunoassay (EIA)Cotinine (nicotine metabolite) IVD kit enzyme immunoassay (EIA)IVD General
Cotinine (nicotine metabolite) IVD calibratorCotinine (nicotine metabolite) IVD calibratorIVD General
Cotinine (nicotine metabolite) IVD controlCotinine (nicotine metabolite) IVD controlIVD General
Fentanyl IVD calibratorFentanyl IVD calibratorIVD General
Fentanyl IVD controlFentanyl IVD controlIVD General
Fentanyl IVD reagentFentanyl IVD reagentIVD General
Lysergic acid diethylamide (LSD)/LSD metabolite IVD calibratorLysergic acid diethylamide (LSD)/LSD metabolite IVD calibratorIVD General
Lysergic acid diethylamide (LSD)/LSD metabolite IVD reagentLysergic acid diethylamide (LSD)/LSD metabolite IVD reagentIVD General
Methaqualone IVD kit radioimmunoassayMethaqualone IVD kit radioimmunoassayIVD General
Phenobarbital IVD kit enzyme immunoassay (EIA)Phenobarbital IVD kit enzyme immunoassay (EIA)IVD General
Negative control immunoglobulin IVDNegative control immunoglobulin IVDIVD General
Total thyroxine (TT4) IVD kit enzyme immunoassay (EIA)Total thyroxine (TT4) IVD kit enzyme immunoassay (EIA)IVD General
Total thyroxine (TT4) IVD calibratorTotal thyroxine (TT4) IVD calibratorIVD General
Valproic acid therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Valproic acid therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Theophylline therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Theophylline therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Drug/toxicology adulteration IVD kit spectrophotometryDrug/toxicology adulteration IVD kit spectrophotometryIVD General
Multiple immunosuppressant therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Multiple immunosuppressant therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Multiple immunosuppressant therapeutic drug monitoring IVD calibratorMultiple immunosuppressant therapeutic drug monitoring IVD calibratorIVD General
Multiple immunosuppressant therapeutic drug monitoring IVD controlMultiple immunosuppressant therapeutic drug monitoring IVD controlIVD General
Ethyl glucuronide (EtG) IVD kit enzyme immunoassay (EIA)Ethyl glucuronide (EtG) IVD kit enzyme immunoassay (EIA)IVD General
Ethyl glucuronide (EtG) IVD calibratorEthyl glucuronide (EtG) IVD calibratorIVD General
Ethyl glucuronide (EtG) IVD controlEthyl glucuronide (EtG) IVD controlIVD General
Gentamicin therapeutic drug monitoring IVD kit nephelometry/turbidimetryGentamicin therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Topiramate therapeutic drug monitoring IVD kit nephelometry/turbidimetryTopiramate therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Lamotrigine therapeutic drug monitoring IVD kit nephelometry/turbidimetryLamotrigine therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Tobramycin therapeutic drug monitoring IVD kit nephelometry/turbidimetryTobramycin therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlIVD General
Digoxin therapeutic drug monitoring IVD calibratorDigoxin therapeutic drug monitoring IVD calibratorIVD General
Valproicacidtherapeutic drug monitoring IVD kit nephelometry/turbidimetryValproicacidtherapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Gentamicintherapeutic drug monitoring IVD kit chemiluminescent immunoassayGentamicintherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Hepatitis B virus antigen/antibody marker IVD controlHepatitis B virus antigen/antibody marker IVD controlIVD Annex II List A
Hepatitis C virus antibody/antigen IVD controlHepatitis C virus antibody/antigen IVD controlIVD Annex II List A
HIV1 nucleic acid IVD controlHIV1 nucleic acid IVD controlIVD Annex II List A
Multiple-type sexually transmitted pathogen nucleic acid IVD controlMultiple-type sexually transmitted pathogen nucleic acid IVD controlIVD Annex II List A
PCR/NAT negative control IVDPCR/NAT negative control IVDIVD Annex II List A
Multiple-therapy therapeutic drug monitoring IVD calibratorMultiple-therapy therapeutic drug monitoring IVD calibratorIVD General
Digoxin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Digoxin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Multiple drugs of abuse IVD controlMultiple drugs of abuse IVD controlIVD General
Methadone IVD kit enzyme immunoassay (EIA)Methadone IVD kit enzyme immunoassay (EIA)IVD General
Vancomycin therapeuticdrug monitoringIVD kitnephelometry/turbidimetryVancomycin therapeuticdrug monitoringIVD kitnephelometry/turbidimetryIVD General
Amikacin therapeutic drug monitoring IVD kit nephelometry/turbidimetryAmikacin therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Carbamazepine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Carbamazepine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)IVD General
Tricyclic antidepressant IVD kit fluorescent immunoassayTricyclic antidepressant IVD kit fluorescent immunoassayIVD General
Propoxyphene IVD kit enzyme immunoassay (EIA)Propoxyphene IVD kit enzyme immunoassay (EIA)IVD General
Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA)Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA)IVD General
Oxycodone IVD reagentOxycodone IVD reagentIVD General
Oxycodone IVD calibratorOxycodone IVD calibratorIVD General
Oxycodone IVD controlOxycodone IVD controlIVD General
Opiate/opiate metabolite IVD calibratorOpiate/opiate metabolite IVD calibratorIVD General
Tobramycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Tobramycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Amphetamine/methamphetamine group IVD kit enzyme immunoassay (EIA)Amphetamine/methamphetamine group IVD kit enzyme immunoassay (EIA)IVD General
Ethanol (ETOH) IVD controlEthanol (ETOH) IVD controlIVD General
Ethanol (ETOH) IVD calibratorEthanol (ETOH) IVD calibratorIVD General
Ethanol (ETOH) IVD kit enzyme spectrophotometryEthanol (ETOH) IVD kit enzyme spectrophotometryIVD General
Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Cannabinoid IVD kit enzyme immunoassay (EIA)Cannabinoid IVD kit enzyme immunoassay (EIA)IVD General
Benzodiazepine group IVD kit enzyme immunoassay (EIA)Benzodiazepine group IVD kit enzyme immunoassay (EIA)IVD General
Barbiturate IVD kit enzyme immunoassay (EIA)Barbiturate IVD kit enzyme immunoassay (EIA)IVD General
Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)IVD General
Multiple drugs of abuse IVD calibratorMultiple drugs of abuse IVD calibratorIVD General
Tobramycin therapeutic drug monitoring IVD calibratorTobramycin therapeutic drug monitoring IVD calibratorIVD General
Cannabinoid IVD calibratorCannabinoid IVD calibratorIVD General
Cannabinoid IVD controlCannabinoid IVD controlIVD General
Drug-testing specimen collection kit IVDDrug-testing specimen collection kit IVDClass A