Duns Number:086785110
Device Description: VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
Catalog Number
-
Brand Name
VITEK®2
Version/Model Number
9.01.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 03, 2020
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
N50510,N50510
Product Code
LON
Product Code Name
SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Public Device Record Key
4aec6f19-93f8-414c-955a-9596387c1751
Public Version Date
March 01, 2022
Public Version Number
3
DI Record Publish Date
December 07, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |