Catalog Number

03L3920

Brand Name

ARCHITECT

Version/Model Number

3L39-20

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

K930529

Product Code

JXM

Product Code Name

ENZYME IMMUNOASSAY, BENZODIAZIPINE

Public Device Record Key

0ca3f240-dd7b-47cf-a19f-cdc1e9d9534a

Public Version Date

October 12, 2020

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

-