Catalog Number

8125-300A

Brand Name

Monobind AccuBind T3 SBS ELISA Kit - 96 Wells

Version/Model Number

8125-300

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

CDP

Product Code Name

RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Public Device Record Key

07c2401b-8db2-4faa-b7a3-98a33189e7af

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-