Catalog Number

12009799

Brand Name

GS

Version/Model Number

12009799

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

137faa7c-690f-469a-aad5-fe7d1c60c6c7

Public Version Date

January 23, 2020

Public Version Number

3

DI Record Publish Date

July 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-