ARK DIAGNOSTICS INC

Address:48089 Fremont Blvd,Fremont,CA,94538,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Immunoassay, Opiates (DJG) (5) Calibrators, Drug Specific (DLJ) (2) Drug Specific Control Materials (LAS) (2) Enzyme Immunoassay, Methotrexate (LAO) (1)

Premarket Exempt

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ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator - 00812101030523 Catalog Number : 5073-0002-02

Device Description : ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator is intended for use in cali ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Assay.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator - 00812101030530 Catalog Number : 5073-0002-03

Device Description : ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator is intended for use in cali ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Assay.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

ARK™ HS Benzodiazepine II 75/125ng/mL Control - 00812101030547 Catalog Number : 5073-0003-00

Device Description : ARK™ HS Benzodiazepine II 75/125ng/mL Control is intended for use in quality con ARK™ HS Benzodiazepine II 75/125ng/mL Control is intended for use in quality control of the ARK™ HS Benzodiazepine II Assay.

Device Class : 1

Duns Number: 164880598

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

ARK™ HS Benzodiazepine II 150/250ng/mL Control - 00812101030554 Catalog Number : 5073-0003-01

Device Description : ARK™ HS Benzodiazepine II 150/250ng/mL Control is intended for use in quality co ARK™ HS Benzodiazepine II 150/250ng/mL Control is intended for use in quality control of the ARK™ HS Benzodiazepine II Assay.

Device Class : 1

Duns Number: 164880598

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

ARK™ Fentanyl II Assay - 00812101030561 Catalog Number : 5069-0001-00

Device Description : The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative deter The ARK™ Fentanyl II Assay 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

Product Code : DJG

Prescription Use : Yes

Device Count : 1

ARK™ Fentanyl II Assay - 00812101030578 Catalog Number : 5069-0001-01

Device Description : The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detec The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

ARK™ Fentanyl II Assay - 500mL - 00812101030585 Catalog Number : 5069-0001-02

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

ARK™ Fentanyl II Assay - 500mL (WPT) - 00812101030622 Catalog Number : 5072-0001-00

Device Description : The ARK™ Fentanyl II Assay is a homogeneous enzyme immunoassay intended for the The ARK™ Fentanyl II Assay is a homogeneous enzyme immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 0.5 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine on automated clinical chemistry analyzers.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

ARK™ Methotrexate Assay - 00812101030639 Catalog Number : 5026-0001-03

Device Description : The ARK Methotrexate Assay c-Pack (cobas c pack green reagent packs) is a homoge The ARK Methotrexate Assay c-Pack (cobas c pack green reagent packs) 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

Product Code : LAO

Prescription Use : Yes

Device Count : 1

DRI™ Fentanyl II Assay - 00812101030752 Catalog Number : 10028872

Device Description : The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detec The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

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