Catalog Number

01E1320

Brand Name

ARCHITECT

Version/Model Number

1E13-20

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

-

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

K030405

Product Code

LEG

Product Code Name

ENZYME IMMUNOASSAY, VALPROIC ACID

Public Device Record Key

06a92ff5-8e45-4d21-be08-349b54230559

Public Version Date

October 21, 2019

Public Version Number

5

DI Record Publish Date

June 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-