Catalog Number

11660551216

Brand Name

Tinaquant 2Microglobulin

Version/Model Number

11660551216

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K980724

Product Code

JZG

Product Code Name

SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL

Public Device Record Key

08a426f6-3914-429d-bc44-6de05b6fb7e9

Public Version Date

October 10, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-