Duns Number:086785110
Device Description: The VITEK ® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 to de The VITEK ® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of S. pneumo , beta-hemolytic Strep, & Viridans Strep
Catalog Number
-
Brand Name
VITEK® 2 AST-ST01
Version/Model Number
VITEK®2 AST-ST01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2019
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
K111599,K111893,K111909,K111976,K112000,K112075,K112129,K112228,K113305,K121100,K121863,K122359,K111599,K111893,K111909,K111976,K112000,K112075,K112129,K112228,K113305,K121100,K121863,K122359
Product Code
LON
Product Code Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Public Device Record Key
d68e1a47-9406-4ce3-9403-618d144b9f24
Public Version Date
November 18, 2021
Public Version Number
4
DI Record Publish Date
January 09, 2017
Package DI Number
03573026345334
Quantity per Package
20
Contains DI Package
03573026529741
Package Discontinue Date
October 08, 2019
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 |