Catalog Number

RE62149

Brand Name

17beta-Estradiol Saliva Luminescence Immunoassay

Version/Model Number

RE62149

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CHP

Product Code Name

Radioimmunoassay, Estradiol

Public Device Record Key

398ef925-ac73-4431-9674-6bd509281855

Public Version Date

January 06, 2021

Public Version Number

1

DI Record Publish Date

December 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-