Catalog Number

800363-100

Brand Name

MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100

Version/Model Number

800363-100

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OLD

Product Code Name

Internal Polymerase Chain Reaction Control, Not Assay Specific

Public Device Record Key

d07a7b58-1921-423a-a4c1-5304cde21d45

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

April 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-