Catalog Number

08814848190

Brand Name

Elecsys HBsAg II

Version/Model Number

08814848190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P160019

Product Code

LOM

Product Code Name

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

Public Device Record Key

b78395b4-cb4b-4dc4-9387-e09d29e21bac

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-