Duns Number:045623154
Device Description: Pointe CRP Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 60ml R2. For Pointe CRP Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 60ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only.
Catalog Number
16-C7568-480
Brand Name
Pointe CRP Reagent
Version/Model Number
16-C7568-480
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)
Yes
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
5114e648-bc19-46eb-a577-3f93c668366b
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 30, 2021
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 |