Catalog Number

07574690190

Brand Name

Elecsys IGFBP-3

Version/Model Number

07574690190

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

-

Product Code

CFL

Product Code Name

RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Public Device Record Key

7ee02534-448b-48f4-9a2d-27857250d946

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

September 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-