Duns Number:315786293
Device Description: Alinity c Phosphorus Reagent Kit 8500 test
Catalog Number
08P4030
Brand Name
Alinity
Version/Model Number
08P4030
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
CEO
Product Code Name
Phosphomolybdate (colorimetric), inorganic phosphorus
Public Device Record Key
1a577024-1ec4-4897-b13b-0154bd364ff9
Public Version Date
May 06, 2021
Public Version Number
3
DI Record Publish Date
July 11, 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 |