Duns Number:079226220
Device Description: Alinity c Carbamazepine Reagent Kit 400 Test
Catalog Number
08P5820
Brand Name
Alinity
Version/Model Number
08P5820
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
K123518
Product Code
KLT
Product Code Name
ENZYME IMMUNOASSAY, CARBAMAZEPINE
Public Device Record Key
efbdb53f-384e-4d27-b46b-ef7ea2169e78
Public Version Date
August 19, 2021
Public Version Number
2
DI Record Publish Date
December 09, 2019
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 |