Catalog Number

L2MCCVM

Brand Name

IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC

Version/Model Number

10373676

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P030040

Product Code

LOM

Product Code Name

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

Public Device Record Key

95efffc1-5e56-4b8c-9d65-f962c4520d7d

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

December 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-