Duns Number:052423787
Device Description: The Aerospray Hematology Pro Slide Stainer/Cytocentrifuge (Model 7152) is intended for use The Aerospray Hematology Pro Slide Stainer/Cytocentrifuge (Model 7152) is intended for use by medical professionals to stain specimens that may include blood and other body fluids, as a step of standard laboratory practice in diagnosing disease in humans. The optional Cytopro rotor allows preparation of slides by cytocentrifugation before staining.
Catalog Number
-
Brand Name
Aerospray Hematology Pro Slide Stainer/Cytocentrifuge
Version/Model Number
Model 7152
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPA
Product Code Name
Slide Stainer, Automated
Public Device Record Key
3b708abb-2539-4c23-bfeb-fc0c1c538f9e
Public Version Date
February 22, 2021
Public Version Number
3
DI Record Publish Date
September 24, 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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |