Catalog Number

-

Brand Name

AgaMatrix

Version/Model Number

8000-10519

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

37a80bb7-c220-4e72-a5a6-eb9594551012

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

November 04, 2016

Package DI Number

20385541003203

Quantity per Package

48

Contains DI Package

00385541003209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper