Identity
- Trade Name
- CyFlow™ HLA-DR APC-Cy7 FDA UDI
- Generic Name
- Multiple CD cell marker IVD, antibody FDA UDI
- Device Name
- The reagent may have application in various test methodologies, including Flow Cytometry. Vial has sufficient volume for 100 tests, if used at 10 uL / test. The reagent is provided in stabilizing phosphate buffered saline (PBS) solution, pH 7.4, containing 0.09% (w/v) sodium azide. FDA UDI
- Model / Reference
- BT262476 FDA UDI
- Description
- The reagent may have application in various test methodologies, including Flow Cytometry. Vial has sufficient volume for 100 tests, if used at 10 uL / test. The reagent is provided in stabilizing phosphate buffered saline (PBS) solution, pH 7.4, containing 0.09% (w/v) sodium azide. FDA UDI
Identifiers
- Catalog Number
- BT262476 FDA UDI
- Primary DI / UDI-DI
- 08595715448695 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Multiple CD cell marker IVD, antibody 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Multiple CD cell marker IVD, antibody
CyFlow™ HLA-DR APC-Cy7 by EXBIO Praha, a.s. — 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
- EXBIO Praha, a.s.
Sources (1)
- FDA UDI d072bd0e-a5f9-4a38-9b0a-e686c99b14db 37 fields · synced May 30, 2026