Catalog Number

403618

Brand Name

Anti-Human IgG Conjugate

Version/Model Number

403618

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071781

Product Code

LCO

Product Code Name

Platelet Factor 4 Radioimmunoassay

Public Device Record Key

3039b776-9a98-4403-b712-bab804a0d35d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-