Catalog Number

11876309160

Brand Name

Elecsys PreciControl HBsAg

Version/Model Number

11876309160

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 04, 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

P990012,P990012,P990012,P990012,P990012

Product Code

LOM

Product Code Name

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

Public Device Record Key

3e9bcb8b-4935-467b-a360-a9ce9804d009

Public Version Date

November 11, 2020

Public Version Number

4

DI Record Publish Date

September 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-