Catalog Number

5073-0002-03

Brand Name

ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator

Version/Model Number

5073-0002-03

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

DLJ

Product Code Name

Calibrators, Drug Specific

Public Device Record Key

af15d90e-8550-44cf-a0f6-7c00a258c4b6

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-