Duns Number:276816717
Device Description: VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used exclusively with the VITEK ® MS instrument.
Catalog Number
-
Brand Name
VITEK® MS-FA
Version/Model Number
VITEK® MS-FA
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
DEN130013,DEN130013
Product Code
PEX
Product Code Name
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Public Device Record Key
2a41b005-cca0-4c83-81c4-da2b443a60ec
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 19, 2016
Package DI Number
03573026362843
Quantity per Package
5
Contains DI Package
03573026555559
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |