Duns Number:086785110
Device Description: The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to measure the The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to measure the optical density of a microorganism suspension.
Catalog Number
-
Brand Name
DensiCHEK™ plus
Version/Model Number
21250
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
K083536
Product Code
LON
Product Code Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Public Device Record Key
b65a4cca-04b7-4202-9843-549715fa88a9
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
November 30, 2016
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 |