Duns Number:276816717
Device Description: DVD to install VITEK MS SW v1.0 and VITEK MS FlexPrep v1.0 for clinical customers
Catalog Number
-
Brand Name
VITEK®MS
Version/Model Number
VITEKMS SW v1.0 / FlexPrep v1.0
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
00366b1d-8c49-4660-bc06-e8023cc2a8a6
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
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 |