Duns Number:075150847
Device Description: The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reacti The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum.Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Catalog Number
EIA-3954
Brand Name
C-Reactive Protein HS ELISA
Version/Model Number
EIA-3954
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"
Yes
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
K003851
Product Code
DCK
Product Code Name
C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
Public Device Record Key
59ad9cbe-8b05-4bd9-817d-d80870eaa11d
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
March 20, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |