Duns Number:071674100
Catalog Number
07886977001
Brand Name
cobas Liat Software Version 3.0
Version/Model Number
07886977001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 12, 2019
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
3880fc09-b27d-4f41-9ac7-3df862a9b765
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
March 01, 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 | 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 |