ARK™ Levetiracetam Calibrator - The ARK™ Levetiracetam Calibrator is intended - ARK DIAGNOSTICS INC

Duns Number:164880598

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

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More Product Details

Catalog Number

5024-0002-00

Brand Name

ARK™ Levetiracetam Calibrator

Version/Model Number

5024-0002-00

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

K091653

Product Code Details

Product Code

DLJ

Product Code Name

Calibrators, Drug Specific

Device Record Status

Public Device Record Key

a8cf738c-7d2d-4b82-99cc-0ba6bddcd5cc

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

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