Identity
- Trade Name
- CytoCell FDA UDI
- Generic Name
- Acute myeloid leukaemia (AML) genetic mutation IVD, probe FDA UDI
- Device Name
- EVI1 (MECOM) Breakapart FISH Probe Kit (IVD (USA)) FDA UDI
- Model / Reference
- USA-LPH036 FDA UDI
- Description
- EVI1 (MECOM) Breakapart FISH Probe Kit (IVD (USA)) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055844923904 FDA UDI
- 510(k) Number
- DEN170070 FDA UDI
- FDA Product Code
- QDI FDA UDI
- GMDN Term
- Acute myeloid leukaemia (AML) genetic mutation IVD, probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1880 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acute myeloid leukaemia (AML) genetic mutation IVD, probeMyelodysplastic syndrome (MDS) IVD, probe
CytoCell by Cytocell, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Myelodysplastic syndrome (MDS) IVD, probe.
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Cleared under the same submission
DEN170070 also covers:
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
- CytoCell — Cytocell, Ltd.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Cytocell, Ltd.
Sources (1)
- FDA UDI f8e41707-5865-4dd3-aa3d-6d291e7ff223 36 fields · synced Jun 6, 2026