Catalog Number

6801816

Brand Name

VITROS

Version/Model Number

6801816

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

P100001,P100001,P100001

Product Code

LOM

Product Code Name

Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Public Device Record Key

ab5fb0b6-b4b8-4b18-96e3-66e0ad3749c6

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

October 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-