Catalog Number

-

Brand Name

IDS-iSYS Insulin like Growth Factor-1 (IGF-1)

Version/Model Number

IS-3900

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

OAM

Product Code Name

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Public Device Record Key

a3702352-a488-42f9-82fd-90ca96be4949

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

April 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-