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Device Description : The ARK™ Ketamine Assay is a homogeneous enzyme immunoassay intended for the qu The ARK™ Ketamine Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of ketamines in human urine at a cutoff concentration of 50 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ketamines in urine on automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Ketamine Assay is intended for the qualitative and semiquantitative de The ARK™ Ketamine Assay is intended for the qualitative and semiquantitative determination of ketamines in human urine at a cutoff concentration of 50 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ketamines in urine and is designated for professional use on automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ Ketamine Calibrator is intended for use in calibration of the ARK™ Ketamine Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ Ketamine Negative Calibrator is intended for use in calibration of the ARK™ ARK™ Ketamine Negative Calibrator is intended for use in calibration of the ARK™ Ketamine Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ Ketamine Cutoff Calibrator is intended for use in calibration of the ARK™ K ARK™ Ketamine Cutoff Calibrator is intended for use in calibration of the ARK™ Ketamine Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ Ketamine Control is intended for use in quality control of the ARK™ Ketamine Assay.
Device Class : 1
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitati The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitati The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ Meperidine Calibrator is intended for use in calibration of the ARK™ Meperi ARK™ Meperidine Calibrator is intended for use in calibration of the ARK™ Meperidine Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ Meperidine Negative Calibrator is intended for use in calibration of the AR ARK™ Meperidine Negative Calibrator is intended for use in calibration of the ARK™ Meperidine Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes