Duns Number:227530649
Device Description: Randox High Sensitivity CRP Control Level I is a ready to use control in a stabilised prot Randox High Sensitivity CRP Control Level I is a ready to use control in a stabilised protein base. It is intended for use with the Randox High Sensitivity CRP Assay (Catalogue No. CP3885) for the control of accuracy and the control of reproducibility.
Catalog Number
-
Brand Name
HIGH SENSITIVITY CRP CONTROL - LEVEL I (hsCRP CONTROL 1)
Version/Model Number
CP2476
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
-
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
54dbb455-fe3c-4c3f-8efa-03559279354e
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
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 |