Duns Number:508663101
Device Description: The body fluid application automatically locates and presents cell images on cytocentrifug The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Catalog Number
CBF-960099
Brand Name
CellaVision® Body Fluid Application DM96
Version/Model Number
CBF-960099
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
K080595
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
a84e7927-1120-419b-85ea-b718f146f398
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
September 20, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |