Catalog Number

LKMC1(D)

Brand Name

IMMULITE®/IMMULITE®1000 Systems BcM Anti-HBc IgM

Version/Model Number

10488615

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P010053,P010053,P010053,P010053

Product Code

LOM

Product Code Name

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

Public Device Record Key

9e1199b6-07f5-4062-b015-d3e897028f01

Public Version Date

November 18, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-