Catalog Number

NC-505001

Brand Name

ASI CRP Control Set

Version/Model Number

NC-505001

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

K821388

Product Code

DCN

Product Code Name

System, Test, C-Reactive Protein

Public Device Record Key

2d333ffd-bfdf-4520-bb32-fd6ff4778786

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-