Duns Number:079226220
Device Description: Alinity c CRP Vario Reagent Kit 3500 CRP HS Tests, 2900 CRP WR Tests
Catalog Number
07P5621
Brand Name
Alinity
Version/Model Number
07P5621
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
-
Product Code
DCK
Product Code Name
C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
Public Device Record Key
2d5fd782-0e2e-4e10-8e8e-86f65acb88ca
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
January 13, 2020
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 | 259 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 245 |
| U | Unclassified | 5 |