Duns Number:052423787
Device Description: The Aerospray TB Slide Stainer/Cytocentrifuge (Model 7722) is a dual-purpose stainer inten The Aerospray TB Slide Stainer/Cytocentrifuge (Model 7722) is a dual-purpose stainer intended for in vitro diagnostic use by medical professionals to stain microbiological specimens suspected of containing acid-fast organisms, a step in the standard laboratory practice of diagnosing disease in humans. The use of Aerospray TB reagents is required for successful use of this instrument. Adding the optional Cytopro rotor allows preparation of slides by cytocentrifugation before staining.
Catalog Number
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Brand Name
Aerospray TB Slide Stainer/Cytocentrifuge
Version/Model Number
Model 7722
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)
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Over the Counter (OTC)
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Kit
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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
57a2e5e0-db2d-40f4-a117-f6f67e9e328b
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
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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 |