Catalog Number

90-1031

Brand Name

INSTI HIV-1/HIV-2 Control Test

Version/Model Number

90-1031

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2020

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

4a5d0664-ec5e-4e7b-a71d-ba14cc2466b3

Public Version Date

November 03, 2021

Public Version Number

6

DI Record Publish Date

January 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-