Catalog Number

-

Brand Name

Yumizen C1200 CRP

Version/Model Number

1300023877

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

K191993

Product Code

DCK

Product Code Name

C-Reactive Protein, Antigen, Antiserum, And Control

Public Device Record Key

dbf0f2f5-213e-4040-b18e-156879495c02

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

July 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-