Catalog Number

1125-300A

Brand Name

Monobind AccuBind Anti-TPO ELISA Kit - 96 Wells

Version/Model Number

1125-300

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

K971834

Product Code

JNL

Product Code Name

IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY

Public Device Record Key

b3c77505-1018-43eb-8eb9-62139e5dd5f1

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-