Catalog Number

11820613160

Brand Name

Elecsys Anti-HBe

Version/Model Number

11820613160

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P190005

Product Code

LOM

Product Code Name

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Public Device Record Key

b2b079b6-d4c4-45fa-a9ea-f2072f1b9f40

Public Version Date

April 19, 2021

Public Version Number

2

DI Record Publish Date

April 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-