Manufacturer's Devices - ARK Diagnostics Inc.

Address:




48089 Fremont Blvd



Fremont

California 94538

United States


Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International



Cambridge

CB24 9BZ

England United Kingdom




Code/Term Type
Benzodiazepine group IVD controlBenzodiazepine group IVD controlIVD General
Benzodiazepine group IVD kit enzyme immunoassay (EIA)Benzodiazepine group IVD kit enzyme immunoassay (EIA)IVD General
Methotrexate therapeutic drug monitoring IVD calibratorMethotrexate therapeutic drug monitoring IVD calibratorIVD General
Methotrexate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Methotrexate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Multiple anticonvulsant therapeutic drug monitoring IVD calibratorMultiple anticonvulsant therapeutic drug monitoring IVD calibratorIVD General
Multiple anticonvulsant therapeutic drug monitoring IVD controlMultiple anticonvulsant therapeutic drug monitoring IVD controlIVD General
Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA)Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Ketamine/ketamine metabolite IVD controlKetamine/ketamine metabolite IVD controlIVD General
Tramadol IVD controlTramadol IVD controlIVD General
Fentanyl IVD kit enzyme immunoassay (EIA)Fentanyl IVD kit enzyme immunoassay (EIA)IVD General
Pregabalin IVD kit enzyme immunoassay (EIA)Pregabalin IVD kit enzyme immunoassay (EIA)IVD General
Pregabalin IVD calibratorPregabalin IVD calibratorIVD General
Pregabalin IVD controlPregabalin IVD controlIVD General
Voriconazole therapeutic drug monitoring IVD calibratorVoriconazole therapeutic drug monitoring IVD calibratorIVD General
Neurontin (gabapentin) IVD calibratorNeurontin (gabapentin) IVD calibratorIVD General
Neurontin (gabapentin) IVD controlNeurontin (gabapentin) IVD controlIVD General
Gabapentin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Gabapentin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Tramadol IVD kit enzyme immunoassay (EIA)Tramadol IVD kit enzyme immunoassay (EIA)IVD General
Tramadol IVD calibratorTramadol IVD calibratorIVD General
Benzodiazepine group IVD calibratorBenzodiazepine group IVD calibratorIVD General
Ketamine/ketamine metabolite IVD calibratorKetamine/ketamine metabolite IVD calibratorIVD General
Voriconazole therapeutic drug monitoring IVD controlVoriconazole therapeutic drug monitoring IVD controlIVD General
Voriconazole therapeutic drug monitoring IVD reagentVoriconazole therapeutic drug monitoring IVD reagentIVD General
Methotrexate therapeutic drug monitoring IVD controlMethotrexate therapeutic drug monitoring IVD controlIVD General
Fentanyl IVD controlFentanyl IVD controlIVD General
Fentanyl IVD calibratorFentanyl IVD calibratorIVD General
Levetiracetam therapeutic drug monitoring IVD calibratorLevetiracetam therapeutic drug monitoring IVD calibratorIVD General
Levetiracetam therapeutic drug monitoring IVD controlLevetiracetam therapeutic drug monitoring IVD controlIVD General
Levetiracetam therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Levetiracetam therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Lamotrigine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Lamotrigine 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
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD control2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) 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
Pethidine IVD kit enzyme immunoassay (EIA)Pethidine IVD kit enzyme immunoassay (EIA)IVD General
Pethidine IVD controlPethidine IVD controlIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibrator2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibratorIVD General
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD kit enzyme immunoassay (EIA)Synthetic cannabinoid/synthetic cannabinoid metabolite 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
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD controlSynthetic cannabinoid/synthetic cannabinoid metabolite IVD controlIVD General
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD calibratorSynthetic cannabinoid/synthetic cannabinoid metabolite IVD calibratorIVD 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
Pethidine IVD calibratorPethidine IVD calibratorIVD General