Duns Number:315786293
Device Description: Alinity i Syphilis TP Reagent Kit 1200 Tests
Catalog Number
07P6031
Brand Name
Alinity
Version/Model Number
07P6031
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
K153730
Product Code
LIP
Product Code Name
ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
Public Device Record Key
653b03ee-6c5a-433f-93f0-b3cf85ddc3d3
Public Version Date
December 24, 2020
Public Version Number
3
DI Record Publish Date
May 29, 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 | 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 |