Catalog Number

06924107160

Brand Name

PreciControl HIV Gen II

Version/Model Number

06924107160

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BP160050,BP160050,BP190403

Product Code

MZF

Product Code Name

Test, Hiv Detection

Public Device Record Key

e55d9ca6-73c3-4248-a33e-f49f76a69701

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

July 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-