Duns Number:342920388
Device Description: Aged human EDTA-treated whole blood samples (6 days old) were stained with 7-AAD Staining Aged human EDTA-treated whole blood samples (6 days old) were stained with 7-AAD Staining Solution using a lyse-wash procedure and analyzed by flow cytometry using the MACSQuant® Analyzer. For analysis, white blood cells were gated based on forward and side scatter properties and after exclusion of cell debris and red blood cells based on scatter signals. Dead and apoptotic cells were identified by 7-AAD fluorescence.
Catalog Number
-
Brand Name
7-AAD Staining Solution
Version/Model Number
170-081-088
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
b07f0a32-c0de-415b-bca8-84d2019a8a32
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 26, 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 | 88 |