Catalog Number

80-1037

Brand Name

INSTI HIV-1/HIV-2 Test Controls

Version/Model Number

80-1037

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 24, 2016

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

BP090032

Product Code

MZF

Product Code Name

Test, Hiv Detection

Public Device Record Key

35c30569-e539-43db-977f-d330686556a7

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-