Duns Number:086785110
Device Description: VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli
Catalog Number
-
Brand Name
VITEK® 2 AST-XN15
Version/Model Number
VITEK® 2 AST-XN15
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
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
K032861,K040845,K121546,K152075,K161437,K161510,K163006,K163083,K172944,K183360,K183551,N50510,N50510,N50510,N50510,N50510,K032861,K040845,K121546,K152075,K161437,K161510,K163006,K163083,K172944,K183360,K183551,N50510,N50510,N50510,N50510,N50510
Product Code
LON
Product Code Name
SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Public Device Record Key
8f672f92-9ece-4001-a134-d11832f94871
Public Version Date
May 10, 2022
Public Version Number
2
DI Record Publish Date
June 22, 2020
Package DI Number
03573026620288
Quantity per Package
20
Contains DI Package
03573026620295
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |