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

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

Premarket Exempt

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ARK™ Ketamine Assay - 00812101030004 Catalog Number : 5056-0001-00

Device Description : The ARK™ Ketamine Assay is a homogeneous enzyme immunoassay intended for the qu

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

ARK™ Ketamine Assay (115mL) - 00812101030011 Catalog Number : 5056-0001-01

Device Description : The ARK™ Ketamine Assay is intended for the qualitative and semiquantitative de

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

ARK™ Ketamine Calibrator - 00812101030028 Catalog Number : 5056-0002-00

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

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

ARK™ Ketamine Negative Calibrator - 00812101030035 Catalog Number : 5056-0002-01

Device Description : ARK™ Ketamine Negative Calibrator is intended for use in calibration of the ARK™

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

ARK™ Ketamine Cutoff Calibrator - 00812101030042 Catalog Number : 5056-0002-02

Device Description : ARK™ Ketamine Cutoff Calibrator is intended for use in calibration of the ARK™ K

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

ARK™ Ketamine Control - 00812101030059 Catalog Number : 5056-0003-00

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

Product Code : LAS

Prescription Use : Yes

Device Count : 1

ARK™ Meperidine Assay - 00812101030127 Catalog Number : 5039-0001-00

Device Description : The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitati

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

ARK™ Meperidine Assay - 00812101030134 Catalog Number : 5039-0001-01

Device Description : The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitati

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

ARK™ Meperidine Calibrator - 00812101030141 Catalog Number : 5039-0002-00

Device Description : ARK™ Meperidine Calibrator is intended for use in calibration of the ARK™ Meperi

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

ARK™ Meperidine Negative Calibrator - 00812101030158 Catalog Number : 5039-0002-01

Device Description : ARK™ Meperidine Negative Calibrator is intended for use in calibration of the AR

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

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