Catalog Number

4642465190

Brand Name

Valproic Acid ONLINE TDM Valproic Acid

Version/Model Number

4642465190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2019

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

K060690

Product Code

LEG

Product Code Name

ENZYME IMMUNOASSAY, VALPROIC ACID

Public Device Record Key

61816322-f4d3-4da4-9180-fa44e2778e01

Public Version Date

November 11, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-