Duns Number:052423787
Device Description: The Aerospray Gram stainer is an in vitro diagnostic medical device for professional use o The Aerospray Gram stainer is an in vitro diagnostic medical device for professional use only. The Gram stainer has been designed to perform automated Gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics with Elitech Group Gram reagents only.
Catalog Number
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Brand Name
Aerospray® Gram Slide Stainer/Cytocentrifuge
Version/Model Number
Model 7322
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
dbd53c6f-59fc-41a0-8450-2f995c84dd98
Public Version Date
February 23, 2021
Public Version Number
4
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 |