Catalog Number

90-1020

Brand Name

INSTI HIV-1/HIV-2 Antibody Test

Version/Model Number

Without Support

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2015

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

4b4dd6e8-4607-4db6-9c3a-9f0bedeb48c9

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-