Catalog Number

-

Brand Name

IGFBP-3 Elisa

Version/Model Number

KAP1171

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

OAM

Product Code Name

Immunoassay, insulin-like growth factor binding protein-1

Public Device Record Key

e51d43a9-c335-46b8-a4a5-4cee994e3e9a

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

January 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-