Duns Number:052423787
Device Description: The Cytopro Cytocentrifuge rotor is an in vitro diagnostic medical device for fixing biolo The Cytopro Cytocentrifuge rotor is an in vitro diagnostic medical device for fixing biological cell suspensions on glass microscope slides for cytological examination. It is an accessory for use with any Elitech Group Aerospray Slide Stainer/Cytocentrifuge. This manual pertains only to the Series 2 stainer/cytocentrifuge models.
Catalog Number
-
Brand Name
Cytopro® Rotor
Version/Model Number
AC-160
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IFB
Product Code Name
Cytocentrifuge
Public Device Record Key
a33f1391-947c-4f49-aa53-68ef11cf49d3
Public Version Date
March 01, 2021
Public Version Number
1
DI Record Publish Date
February 19, 2021
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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |