Duns Number:508663101
Device Description: Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of bl Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears
Catalog Number
CC286297
Brand Name
Automated Digital Morphology Analyzer DI-60
Version/Model Number
CC286297
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
K092868
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
94bd167b-12d7-4bdb-8171-db4ac2542d1a
Public Version Date
September 16, 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 |