Catalog Number

W2334

Brand Name

NA

Version/Model Number

W2334

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JXM

Product Code Name

Enzyme Immunoassay, Benzodiazepine

Public Device Record Key

cfe3ced0-a462-43cb-a045-5ab6aa6a9c41

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-