Catalog Number

26224

Brand Name

GS

Version/Model Number

26224

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

BP100064

Product Code

MZF

Product Code Name

Test, Hiv Detection

Public Device Record Key

d7a04e5f-fe3f-4f35-9922-37db881e40e2

Public Version Date

July 29, 2021

Public Version Number

6

DI Record Publish Date

August 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-