Identity
- Trade Name
- 7-AAD Staining Solution FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 170-081-088 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133725 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assay development analyte-specific reagent IVD
7-AAD Staining Solution by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Miltenyi Biotec B.V. & Co. KG
Sources (1)
- FDA UDI b07f0a32-c0de-415b-bca8-84d2019a8a32 35 fields · synced Jun 1, 2026