Manufacturer's Devices - Immunalysis Corporation

Address:




829 Towne Center Drive



Pomona

California 91767

United States


Authorised Representative/ UK Responsible Person
Name: Unipath Limited (trading as Alere International)
Address:

Clearblue Innovation Centre Priory Business Park

Stannard Way

Bedford

Bedfordshire MK44 3UP

England United Kingdom




Code/Term Type
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibrator2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibratorIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD control2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD controlIVD 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
6-Acetyl morphine IVD calibrator6-Acetyl morphine IVD calibratorIVD General
6-Acetyl morphine IVD control6-Acetyl morphine IVD controlIVD General
6-Acetyl morphine IVD kit enzyme immunoassay (EIA)6-Acetyl morphine IVD kit enzyme immunoassay (EIA)IVD General
Amphetamine-specific IVD calibratorAmphetamine-specific IVD calibratorIVD General
Amphetamine-specific IVD kit enzyme immunoassay (EIA)Amphetamine-specific IVD kit enzyme immunoassay (EIA)IVD General
Buprenorphine IVD controlBuprenorphine IVD controlIVD General
Buprenorphine IVD kit enzyme immunoassay (EIA)Buprenorphine IVD kit enzyme immunoassay (EIA)IVD General
Cannabinoid/cannabinoid metabolite IVD calibratorCannabinoid/cannabinoid metabolite IVD calibratorIVD General
Cannabinoid/cannabinoid metabolite IVD controlCannabinoid/cannabinoid metabolite IVD controlIVD General
Ethyl glucuronide (EtG) IVD calibratorEthyl glucuronide (EtG) IVD calibratorIVD General
Ethyl glucuronide (EtG) IVD controlEthyl glucuronide (EtG) IVD controlIVD General
Ethyl glucuronide (EtG) IVD kit enzyme immunoassay (EIA)Ethyl glucuronide (EtG) IVD kit enzyme immunoassay (EIA)IVD General
Fentanyl IVD calibratorFentanyl IVD calibratorIVD General
Fentanyl IVD controlFentanyl IVD controlIVD General
Ketamine/ketamine metabolite IVD calibratorKetamine/ketamine metabolite IVD calibratorIVD General
Amphetamine-specific IVD controlAmphetamine-specific IVD controlIVD General
Ketamine/ketamine metabolite IVD controlKetamine/ketamine metabolite IVD controlIVD General
Morphine/morphine metabolite IVD kit enzyme immunoassay (EIA)Morphine/morphine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Oxycodone IVD calibratorOxycodone IVD calibratorIVD General
Oxycodone IVD controlOxycodone IVD controlIVD General
Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA)Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA)IVD General
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD calibratorSynthetic cannabinoid/synthetic cannabinoid metabolite IVD calibratorIVD General
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD controlSynthetic cannabinoid/synthetic cannabinoid metabolite IVD controlIVD General
Tapentadol IVD calibratorTapentadol IVD calibratorIVD General
Tapentadol IVD kit enzyme immunoassay (EIA)Tapentadol IVD kit enzyme immunoassay (EIA)IVD General
Tramadol IVD calibratorTramadol IVD calibratorIVD General
Tramadol IVD controlTramadol IVD controlIVD General
Buprenorphine IVD calibratorBuprenorphine IVD calibratorIVD General
Methamphetamine-specific IVD kit enzyme immunoassay (EIA)Methamphetamine-specific IVD kit enzyme immunoassay (EIA)IVD General
Tapentadol IVD controlTapentadol IVD controlIVD General
Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)IVD General
Benzodiazepine group IVD kit enzyme immunoassay (EIA)Benzodiazepine group IVD kit enzyme immunoassay (EIA)IVD General
Opiate/opiate metabolite IVD calibratorOpiate/opiate metabolite IVD calibratorIVD General
Barbiturate IVD kit enzyme immunoassay (EIA)Barbiturate IVD kit enzyme immunoassay (EIA)IVD General
Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA)Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Tramadol IVD kit enzyme immunoassay (EIA)Tramadol IVD kit enzyme immunoassay (EIA)IVD General
Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Fentanyl IVD kit enzyme immunoassay (EIA)Fentanyl IVD kit enzyme immunoassay (EIA)IVD General
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD kit enzyme immunoassay (EIA)Synthetic cannabinoid/synthetic cannabinoid metabolite IVD kit enzyme immunoassay (EIA)IVD General
Oxycodone IVD kit enzyme immunoassay (EIA)Oxycodone IVD kit enzyme immunoassay (EIA)IVD General
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorIVD General
Cotinine (nicotine metabolite) IVD kit enzyme immunoassay (EIA)Cotinine (nicotine metabolite) IVD kit enzyme immunoassay (EIA)IVD General
Multiple antidepressant therapeutic drug monitoring IVD reagentMultiple antidepressant therapeutic drug monitoring IVD reagentIVD General
Methadone IVD kit enzyme immunoassay (EIA)Methadone IVD kit enzyme immunoassay (EIA)IVD General
Zolpidem IVD kit enzyme immunoassay (EIA)Zolpidem IVD kit enzyme immunoassay (EIA)IVD General
Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)IVD General
Salicylate IVD kit enzyme immunoassay (EIA)Salicylate IVD kit enzyme immunoassay (EIA)IVD General
Oral/upper respiratory tract specimen collection kitOral/upper respiratory tract specimen collection kitIVD General
Oral/upper respiratory tract specimen collection kitOral/upper respiratory tract specimen collection kitIVD General
Oral/upper respiratory tract specimen collection kitOral/upper respiratory tract specimen collection kitClass I