Catalog Number

-

Brand Name

QUANTA Flash® M2 (MIT3) Reagents

Version/Model Number

701303

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

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

K163525

Product Code

DBM

Product Code Name

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

8d3c040c-c90a-47b3-b370-bbff007bd500

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

January 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-