Duns Number:315786293
Device Description: Alinity i Anti-CCP Reagent Kit 200 Tests
Catalog Number
09P2720
Brand Name
Alinity
Version/Model Number
09P2720
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
NHX
Product Code Name
ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
Public Device Record Key
43a217e9-077c-447c-9d2f-6ae0b0f0c2d0
Public Version Date
December 01, 2020
Public Version Number
3
DI Record Publish Date
December 04, 2018
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 | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 185 |
| 3 | A medical device with high risk that requires premarket approval | 13 |