CRP - The CRP test system is intended for the - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: The CRP test system is intended for the quantitative in vitro determination of CRP concent The CRP test system is intended for the quantitative in vitro determination of CRP concentration in serum.

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More Product Details

Catalog Number

CP7950

Brand Name

CRP

Version/Model Number

CP7950

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K953212

Product Code Details

Product Code

DCK

Product Code Name

C-Reactive Protein, Antigen, Antiserum, And Control

Device Record Status

Public Device Record Key

8d4819d3-8470-4bcc-805e-dea3f29052b0

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RANDOX LABORATORIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 258