Catalog Number

44511

Brand Name

STABBS Negative

Version/Model Number

44511

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Public Device Record Key

3919c310-53af-46d0-b8d1-591bc6fb7b0d

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Package DI Number

B800445115

Quantity per Package

5

Contains DI Package

B800445110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box