ARK™ Ketamine Assay - The ARK™ Ketamine Assay is a homogeneous enzyme - ARK DIAGNOSTICS INC

Duns Number:164880598

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

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More Product Details

Catalog Number

5056-0001-00

Brand Name

ARK™ Ketamine Assay

Version/Model Number

5056-0001-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DKZ

Product Code Name

Enzyme Immunoassay, Amphetamine

Device Record Status

Public Device Record Key

6c764dfd-1c25-4f25-8f9d-361594296655

Public Version Date

July 31, 2019

Public Version Number

1

DI Record Publish Date

July 23, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARK DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 86
U Unclassified 4