Catalog Number

3438099

Brand Name

ADVIA Centaur® HCV

Version/Model Number

10309061

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P030056,P030056,P030056,P030056,P030056,P030056

Product Code

MZO

Product Code Name

Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus

Public Device Record Key

1e18e764-b71c-4a5c-8a85-b31f19b0f941

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-