Duns Number:071674100
Catalog Number
09260994001
Brand Name
cobas® Liat® Analyzer Software 3.3
Version/Model Number
09260994001
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
OOI
Product Code Name
real time Nucleic acid amplification system
Public Device Record Key
bbdb212e-61a5-4245-9e92-7b5d9b532bee
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
July 23, 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 | 41 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |
3 | A medical device with high risk that requires premarket approval | 29 |