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Sign in to claim this brandEXBIO Praha, a.s.
US
Last updated May 24, 2026
What EXBIO Praha, a.s. makes
The company manufactures in vitro diagnostic (IVD) reagents designed for identifying cell surface markers in multiple CD cell types. These products include fluorescently labeled antibodies for flow cytometry applications, such as CyFlow™ CD123 PerCP-Cy5.5 and CyFlow™ CD27 FITC, which target specific antigens like CD123 and CD27. Additional markers include CyFlow™ CD81 Alexa Fluor™ 700, CyFlow™ CD10 Alexa Fluor™ 700, and CyFlow™ Ki-67 PE, among others. These reagents are used to analyze cell populations in research and clinical diagnostics.
The portfolio consists of Class I devices, which are generally considered low-risk and subject to minimal regulatory oversight. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The company operates from the United States, adhering to applicable IVD regulations for these diagnostic tools.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does EXBIO Praha, a.s. manufacture?
EXBIO Praha, a.s. specializes in in vitro diagnostic (IVD) reagents, specifically fluorescently labeled antibodies for flow cytometry. These products are designed to identify and analyze cell surface markers in multiple CD cell types, such as CyFlow™ CD123 PerCP-Cy5.5 or CyFlow™ CD27 FITC. These reagents help researchers and clinicians study cell populations in research and clinical diagnostics.
Where is EXBIO Praha, a.s. based, and what does that mean for its regulatory compliance?
EXBIO Praha, a.s. is based in the United States, which means its IVD products must comply with U.S. regulatory requirements. Since these devices fall under Class I classification—considered low-risk—they are subject to minimal regulatory oversight, though they are still required to meet FDA standards for safety and performance. The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance.
Which regulatory registries list EXBIO Praha, a.s.’s devices?
EXBIO Praha, a.s.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product is traceable and meets U.S. regulatory requirements, particularly for Class I IVD reagents like their CyFlow™ antibody conjugates. Listing in the UDI database is a key compliance step for manufacturers to demonstrate regulatory adherence.
How are EXBIO Praha, a.s.’s devices classified under U.S. regulations?
EXBIO Praha, a.s.’s devices are classified as Class I in vitro diagnostics (IVDs). This classification is assigned based on risk assessment—Class I devices are generally considered low-risk and pose minimal harm to patients or users. As a result, they require minimal regulatory oversight, though they must still comply with FDA requirements for labeling, manufacturing controls, and UDI registration to ensure safety and proper use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sysmex.com
- —
- —
- [email protected]
- Phone
- 1-888-879-7639
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 495024965
Catalogue (236)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CyFlow™ HLA-DR FITC | BS114677 | FDA UDI | Class I | Active |
| CyFlow™ CD2 PE | AT331837 | FDA UDI | Class I | Active |
| CyFlow™ TdT FITC | CE881363 | FDA UDI | Class I | Active |
| CyFlow™ CD24 Alexa Fluor™ 700 | BY712767 | FDA UDI | Class I | Active |
| CyFlow™ CD64 PE-Cy7 | CD155998 | FDA UDI | Class I | Active |
| CyFlow™ CD7 FITC | BF399906 | FDA UDI | Class I | Active |
| CyFlow™ CD8 PE-Cy5 | CZ173018 | FDA UDI | Class I | Active |
| CyFlow™ CD27 Pacific Blue™ | AL442895 | FDA UDI | Class I | Active |
| CyFlow™ IgM PerCP-Cy5.5 | BM298540 | FDA UDI | Class I | Active |
| CyFlow™ CD25 APC | CM345107 | FDA UDI | Class I | Active |
| CyFlow™ CD11c FITC | AG248041 | FDA UDI | Class I | Active |
| CyFlow™ CD64 FITC | CB580553 | FDA UDI | Class I | Active |
| CyFlow™ CD200 PE | CC514079 | FDA UDI | Class I | Active |
| CyFlow™ CD7 Pacific Blue™ | CP122623 | FDA UDI | Class I | Active |
| CyFlow™ CD25 FITC | BZ784311 | FDA UDI | Class I | Active |
| CyFlow™ CD11b Alexa Fluor™ 700 | CN042483 | FDA UDI | Class I | Active |
| CyFlow™ HLA-DR Alexa Fluor™ 700 | CN383443 | FDA UDI | Class I | Active |
| CyFlow™ CD79a PerCP-Cy5.5 | BE679874 | FDA UDI | Class I | Active |
| CyFlow™ CD3 APC-Cy7 | AX394879 | FDA UDI | Class I | Active |
| CyFlow™ TCR gamma/delta PE | BM064167 | FDA UDI | Class I | Active |
| CyFlow™ IFN-gamma FITC | BR971706 | FDA UDI | Class I | Active |
| CyFlow™ TCR gamma/delta FITC | AY624809 | FDA UDI | Class I | Active |
| CyFlow™ CD61 FITC | CT969865 | FDA UDI | Class I | Active |
| CyFlow™ CD38 PE | AR720156 | FDA UDI | Class I | Active |
| CyFlow™ CD27 PE | CH744525 | FDA UDI | Class I | Active |
| CyFlow™ CD24 PE-DyLight™ 594 | AB228756 | FDA UDI | Class I | Active |
| CyFlow™ CD123 FITC | AV296074 | FDA UDI | Class I | Active |
| CyFlow™ CD8 FITC | BL810715 | FDA UDI | Class I | Active |
| CyFlow™ MPO FITC | AL616617 | FDA UDI | Class I | Active |
| CyFlow™ CD71 Alexa Fluor™ 700 | CY779764 | FDA UDI | Class I | Active |
| CyFlow™ CD41 FITC | AQ110249 | FDA UDI | Class I | Active |
| CyFlow™ CD1a APC | CE793516 | FDA UDI | Class I | Active |
| CyFlow™ CD117 PE-Cy7 | CF030503 | FDA UDI | Class I | Active |
| CyFlow™ CD34 PE | CU768963 | FDA UDI | Class I | Active |
| CyFlow™ CD3 Pacific Blue™ | AV006866 | FDA UDI | Class I | Active |
| CyFlow™ CD13 PE-Cy7 | AR629883 | FDA UDI | Class I | Active |
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