Duns Number:079226220
Device Description: Alinity c Serum Benzodiazepines Reagent Kit 400 Tests
Catalog Number
09P5320
Brand Name
Alinity
Version/Model Number
09P5320
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
K960708
Product Code
JXM
Product Code Name
Enzyme immunoassay, benzodiazepine
Public Device Record Key
26c92eb8-7db7-40e1-988a-69d9230114c7
Public Version Date
August 19, 2021
Public Version Number
2
DI Record Publish Date
February 10, 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 |