Catalog Number

6802454

Brand Name

VITROS

Version/Model Number

6802454

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

-

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

P010021,P010021,P010021,P010021

Product Code

MZO

Product Code Name

ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Public Device Record Key

2118e3d4-1352-427b-8cb4-a94e01d68b96

Public Version Date

April 26, 2021

Public Version Number

5

DI Record Publish Date

October 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-