Catalog Number

3525-300A

Brand Name

Monobind AccuBind TBG ELISA Kit - 96 Wells

Version/Model Number

3525-300

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

CEE

Product Code Name

Radioimmunoassay, thyroxine-binding globulin

Public Device Record Key

7c8cc1e4-b8da-40a3-b5b3-ad9ba15dc1c7

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-