Catalog Number

07-294106

Brand Name

CT hTSH 1000 Tube Kit

Version/Model Number

07-294106

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

K865071

Product Code

JLW

Product Code Name

RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Public Device Record Key

728f811b-9f69-43ce-8050-c334d06cec3d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-