Duns Number:227530649
Device Description: The device is a latex agglutination slide test intended for qualitative and semi-quantitat The device is a latex agglutination slide test intended for qualitative and semi-quantitative in vitro diagnostic determination of C-Reactive Protein (CRP) concentration in serum.
Catalog Number
CP2714
Brand Name
CRP
Version/Model Number
CP2714
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K954447
Product Code
DCK
Product Code Name
C-Reactive Protein, Antigen, Antiserum, And Control
Public Device Record Key
466044a7-ccd4-48ee-af2d-cfb292e414b5
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |