Catalog Number

OPJC03

Brand Name

N FLC Supplementary Reagent

Version/Model Number

10482439

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

K171742

Product Code

DFH

Product Code Name

KAPPA, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

291a3312-bd16-4e80-b08a-a9126990af53

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

February 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-