Duns Number:086785110
Device Description: These are calibration standards for the DensiCHEK™ Plus instrument which is designed for u These are calibration standards for the DensiCHEK™ Plus instrument which is designed for use with the VITEK®2 to measure the optical density of a bacterial suspension.
Catalog Number
-
Brand Name
DensiCHEK™ CALIBRATION STANDARD
Version/Model Number
DensiCHEK™ CALIBRATION STANDARD
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,K083536
Product Code
LON
Product Code Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Public Device Record Key
40051d02-e918-43e4-9167-3c1ff9f26f9d
Public Version Date
May 10, 2021
Public Version Number
6
DI Record Publish Date
December 19, 2016
Package DI Number
03573026103156
Quantity per Package
1
Contains DI Package
03573026551155
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 |