Address:48089 Fremont Blvd,Fremont,CA,94538,US
Device Description : The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the q The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : DRI™ Fentanyl II Negative Calibrator (Thermo Fisher) is intended for use in the DRI™ Fentanyl II Negative Calibrator (Thermo Fisher) is intended for use in the calibration of the DRI™ Fentanyl II Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : DRI™ Fentanyl II Cutoff Calibrator (Thermo Fisher) is intended for use in the ca DRI™ Fentanyl II Cutoff Calibrator (Thermo Fisher) is intended for use in the calibration of the DRI™ Fentanyl II Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : DRI™ Fentanyl II Control (Thermo Fisher) is intended for use in quality control DRI™ Fentanyl II Control (Thermo Fisher) is intended for use in quality control of the DRI™ Fentanyl II Assay.
Device Class : 1
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the q The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The ARK™ Zonisamide Assay consists of reagents RI anti-zonisamide polyclonal antibody with substrate and R2 zonisamide epitope labeled with bacterial G6PDH enzyme.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with Lamotrigine. The ARK™ Lamotrigine Assay consists of reagents RI anti-Lamotrigine polyclonal antibody with substrate and R2 Lamotrigine epitope labeled with bacterial G6PDH enzyme.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for t The ARK™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with Levetiracetam. The ARK™ Levetiracetam Assay consists of reagents RI anti-Levetiracetam polyclonal antibody with substrate and R2 Levetiracetam epitope labeled with bacterial G6PDH enzyme.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the q The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
Device Class : U
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes