Catalog Number

10492004

Brand Name

VERSANT HCV 2.0 LiPA

Version/Model Number

10492004

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

P160016

Product Code

OBF

Product Code Name

Assay, genotyping, hepatitis c virus

Public Device Record Key

56c18095-2e8e-4c20-bf8d-1c68865672d6

Public Version Date

November 19, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-