Duns Number:227530649
Device Description: The device is intended for in vitro diagnostic use in the calibration of CRP assays on cli The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems.
Catalog Number
CP2179
Brand Name
CRP CAL
Version/Model Number
CP2179
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
K022682
Product Code
JIS
Product Code Name
Calibrator, Primary
Public Device Record Key
ea4888c6-a8b9-452a-bd38-3f02f97dbb1e
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 |