Catalog Number

OPJA075

Brand Name

N LATEX FLC KAPPA

Version/Model Number

10873629

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

-

Product Code

DFH

Product Code Name

KAPPA, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

b2c1a2ac-43b1-49b0-9a9b-5830bd6338c2

Public Version Date

November 18, 2021

Public Version Number

10

DI Record Publish Date

January 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-