Catalog Number

-

Brand Name

Human Beta-2 Microglobulin Latex Kit for use on the Siemens BN™II

Version/Model Number

LK043.T

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K946069

Product Code

JZG

Product Code Name

System, Test, Beta-2-Microglobulin Immunological

Public Device Record Key

68eac3c7-2264-4da1-82af-26c1e8ca562d

Public Version Date

October 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-