Catalog Number

03290379160

Brand Name

Elecsys PreciControl Anti-HCV

Version/Model Number

03290379160

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 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

Yes

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

-

Product Code

MZO

Product Code Name

ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Public Device Record Key

310385a5-fdd6-4edc-a905-18472b44aa18

Public Version Date

October 01, 2018

Public Version Number

3

DI Record Publish Date

December 18, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-