Catalog Number

25228

Brand Name

Bio-Rad

Version/Model Number

25228

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2017

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)

Yes

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

BP040046

Product Code

MZF

Product Code Name

Test, Hiv Detection

Public Device Record Key

231c23fd-51d4-44b3-b206-8c7140130e7c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-