Catalog Number

-

Brand Name

Salivary Cortisol ELISA

Version/Model Number

IB79305

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 10, 2019

Issuing Agency

In HIBCC

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

NHG

Product Code Name

Enzyme Immunoassay, Cortisol, Salivary

Public Device Record Key

b5383c24-f437-42dd-a2c9-41eb37b19933

Public Version Date

September 11, 2019

Public Version Number

2

DI Record Publish Date

October 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-