Duns Number:878263359
Device Description: Alinity m Pipette Tips, 1000uL
Catalog Number
09N26-002
Brand Name
Alinity m
Version/Model Number
09N26-002
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OOI
Product Code Name
real time Nucleic acid amplification system
Public Device Record Key
8504e15e-b1c1-4afd-b8fb-27c602e21580
Public Version Date
September 02, 2022
Public Version Number
4
DI Record Publish Date
April 29, 2020
Package DI Number
20884999047857
Quantity per Package
8
Contains DI Package
00884999047853
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |