Duns Number:079226220
Device Description: Alinity c Cocaine Reagent Kit 500 Tests
Catalog Number
09P5520
Brand Name
Alinity
Version/Model Number
09P5520
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
K181499
Product Code
DIO
Product Code Name
Enzyme immunoassay, cocaine and cocaine metabolites
Public Device Record Key
21bf9a91-723d-4f99-b8aa-9c2ed15e8927
Public Version Date
August 19, 2021
Public Version Number
2
DI Record Publish Date
March 27, 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 |