Duns Number:086785110
Device Description: The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents
Catalog Number
-
Brand Name
VITEK® 2 AST-YS05
Version/Model Number
VITEK® 2 AST-YS05
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 19, 2021
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
Yes
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
K061945,K092454,K101566,K061945,K092454,K101566
Product Code
NGZ
Product Code Name
Susceptibility Test Plate, Antifungal
Public Device Record Key
2aee0d89-b816-494c-bfa3-ded8a0d64058
Public Version Date
May 10, 2022
Public Version Number
4
DI Record Publish Date
January 09, 2017
Package DI Number
03573026373047
Quantity per Package
20
Contains DI Package
03573026529758
Package Discontinue Date
August 19, 2021
Package Status
Not 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |