Duns Number:086785110
Device Description: The POD is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacte The POD is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test.
Catalog Number
-
Brand Name
VITEK® DENSICHEK® POD
Version/Model Number
423000
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
K192110
Product Code
LON
Product Code Name
SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Public Device Record Key
bd561756-aa45-41e9-9762-dc0e0ad5c319
Public Version Date
April 26, 2022
Public Version Number
3
DI Record Publish Date
December 06, 2019
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 |