Duns Number:276816717
Device Description: VITEK MS SW V1.1 + KB 3.2
Catalog Number
-
Brand Name
VITEK®MS
Version/Model Number
VITEK MS SW V1.1
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
K162950,K181412
Product Code
PEX
Product Code Name
System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
Public Device Record Key
4ee43db8-89b8-4241-b67c-e39f0606c470
Public Version Date
November 11, 2021
Public Version Number
1
DI Record Publish Date
November 03, 2021
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |