Catalog Number

08362785190

Brand Name

Control Set ß2Microglobulin

Version/Model Number

08362785190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 26, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Public Device Record Key

a9287f7f-c578-4006-be7c-de93d456c87d

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

February 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-