Catalog Number

03155935018

Brand Name

COBAS AMPLICOR HIV-1 Monitor Test, version 1.5

Version/Model Number

2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MTL

Product Code Name

MONITOR,TEST,HIV-1

Public Device Record Key

fc75b6c4-1ae5-448f-b364-f53b15145d76

Public Version Date

November 24, 2020

Public Version Number

3

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-