Duns Number:052423787
Device Description: The Aerospray® Cytology Slide Stainer/Cytocentrifuge Model 7522 is intended for use by lab The Aerospray® Cytology Slide Stainer/Cytocentrifuge Model 7522 is intended for use by laboratory professionals to stain cytology specimens using the Papanicolaou staining method with ELITechGroup Papanicolaou stains only. The optional Cytopro® rotor allows preparation of slides by cytocentrifugation before staining
Catalog Number
Model 7522
Brand Name
Aerospray Cytology Slide Stainer/Cytocentrifuge
Version/Model Number
7522
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
KPA
Product Code Name
Slide Stainer, Automated
Public Device Record Key
bfe9ad93-543b-4ae9-81ff-1b91b0d791aa
Public Version Date
April 07, 2021
Public Version Number
1
DI Record Publish Date
March 30, 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 |