Catalog Number

MIA2-20

Brand Name

JAS Diagnostics

Version/Model Number

MIA2-20

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

-

Product Code

DCF

Product Code Name

Albumin, Antigen, Antiserum, Control

Public Device Record Key

76b5f771-c4d8-47bd-91ce-861c5df436cf

Public Version Date

August 24, 2018

Public Version Number

1

DI Record Publish Date

July 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-