Catalog Number

-

Brand Name

OraSure HIV-1 Western Blot Kit

Version/Model Number

501-0000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2018

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

-

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

BP950004,BP950004,BP950004,BP950004,BP950004,BP950004,BP950004

Product Code

MVZ

Product Code Name

System,Test,Home,Hiv-1

Public Device Record Key

e226451e-63c4-4290-9b3a-05bee4d103c6

Public Version Date

September 14, 2018

Public Version Number

4

DI Record Publish Date

September 05, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-