Address:48089 Fremont Blvd,Fremont,CA,94538,US
Device Description : ARK™ Meperidine Cutoff Calibrator is intended for use in calibration of the ARK™ ARK™ Meperidine Cutoff 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 Control is intended for use in quality control of the ARK™ Meper ARK™ Meperidine Control is intended for use in quality control of the ARK™ Meperidine Assay.
Device Class : 1
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative det The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative det The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ UR-144/JWH-018 Negative Calibrator is intended for use in calibration of th ARK™ UR-144/JWH-018 Negative Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ UR-144/JWH-018 Cutoff Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Cutoff Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ UR-144/JWH-018 Control is intended for use in quality control of the ARK™ U ARK™ UR-144/JWH-018 Control is intended for use in quality control of the ARK™ UR-144/JWH-018 Assay.
Device Class : 1
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determin The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determin The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes
Device Description : ARK™ AB-PINACA Negative Calibrator is intended for use in calibration of the ARK ARK™ AB-PINACA Negative Calibrator is intended for use in calibration of the ARK™ AB-PINACA Assay.
Device Class : 2
Duns Number: 164880598
Premarket Exempt : No
Prescription Use : Yes