Duns Number:388240673
Device Description: Quantitative determination of C-reactive protein (CRP) in human serum and plasma on Siemen Quantitative determination of C-reactive protein (CRP) in human serum and plasma on Siemens Systems
Catalog Number
OQIY13
Brand Name
CardioPhase® hsCRP
Version/Model Number
10446090
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
K033908,K033908
Product Code
NQD
Product Code Name
CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
Public Device Record Key
482837d8-eead-4b7d-afdb-3e0e7740feec
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 24, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |