Catalog Number

-

Brand Name

β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)

Version/Model Number

None

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

-

Product Code

JZG

Product Code Name

System, Test, Beta-2-Microglobulin Immunological

Public Device Record Key

46010ce7-6dd8-4238-bbe6-292e9ab4cbf4

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

March 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-