ARK DIAGNOSTICS INC

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

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- Catalog Number : 5015-0002-00

Device Description : The ARK™ Topiramate Calibrator consists of a six-level set to calibrate the ARK The ARK™ Topiramate Calibrator consists of a six-level set to calibrate the ARK™ Topiramate Assay.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5022-0002-00

Device Description : The ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK™ The ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK™ Zonisamide Assay. .

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5023-0002-00

Device Description : The ARK™ Lamotrigine Calibrator is intended for use in calibration of the ARK The ARK™ Lamotrigine Calibrator is intended for use in calibration of the ARK™ Lamotrigine Assay.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5024-0002-00

Device Description : The ARK™ Levetiracetam Calibrator is intended for use in calibration of the A The ARK™ Levetiracetam Calibrator is intended for use in calibration of the ARK™ Levetiracetam Assay.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5025-0002-00

Device Description : The ARK™ Gabapentin Calibrator is intended for use in calibration of the ARK™ The ARK™ Gabapentin Calibrator is intended for use in calibration of the ARK™ Gabapentin Assay.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5026-0002-00

Device Description : The ARK™ Methotrexate Calibrator consists of a six-level set to calibrate the AR The ARK™ Methotrexate Calibrator consists of a six-level set to calibrate the ARK™ Methotrexate Assay. The calibrators consist of a synthetic protein matrix and the levels are 0.00 umol/L, 0.05 umol/L, 0.15 umol/L, 0.25 umol/L, 0.50 umol/L and 1.2 umol/L.

Device Class : 2

Duns Number: 164880598

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5015-0003-00

Device Description : The ARK™ Topiramate Control consists of a three-level set used for quality cont The ARK™ Topiramate Control consists of a three-level set used for quality control of the ARK™ Topiramate Assay.

Device Class : 1

Duns Number: 164880598

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5022-0003-00

Device Description : The ARK™ Zonisamide Control is intended for use in quality control of the ARK The ARK™ Zonisamide Control is intended for use in quality control of the ARK™Zonisamide Assay.

Device Class : 1

Duns Number: 164880598

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5023-0003-00

Device Description : The ARK™ Lamotrigine Control is intended for use in quality control of the AR The ARK™ Lamotrigine Control is intended for use in quality control of the ARK™Lamotrigine Assay.

Device Class : 1

Duns Number: 164880598

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5024-0003-00

Device Description : The ARK™ Levetiracetam Control is intended for use in quality control of the The ARK™ Levetiracetam Control is intended for use in quality control of the ARK™Levetiracetam Assay.

Device Class : 1

Duns Number: 164880598

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1