Duns Number:045623154
Device Description: The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set is intended to be used for th The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set is intended to be used for the calibration of the manufacturer’s CRP (High Sensitivity) Wide Range immunoturbidimetric assay. For in vitro diagnostic use only.
Catalog Number
C7568-STD
Brand Name
POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L)
Version/Model Number
C7568-STD
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030545
Product Code
DCK
Product Code Name
C-Reactive Protein, Antigen, Antiserum, And Control
Public Device Record Key
e4917e25-a4e2-46da-8fd2-4e89ac1e9de3
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |