Catalog Number

LKVB1

Brand Name

IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12

Version/Model Number

10380900

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

K971177

Product Code

CDD

Product Code Name

RADIOASSAY, VITAMIN B12

Public Device Record Key

196f9fba-2ddd-49c0-bcce-7fcdb10ac2bb

Public Version Date

August 05, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-