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CytoCell

FDA UDI

Class II (US FDA UDI)

by Cytocell, Ltd.

Identity

Trade Name
CytoCell FDA UDI
Generic Name
Acute myeloid leukaemia (AML) genetic mutation IVD, probe FDA UDI
Device Name
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit (IVD (USA)) FDA UDI
Model / Reference
USA-LPH026 FDA UDI
Description
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit (IVD (USA)) FDA UDI

Identifiers

Primary DI / UDI-DI
05055844923898 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, probe

CytoCell by Cytocell, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Acute myeloid leukaemia (AML) genetic mutation IVD, probe.

Cleared under the same submission

DEN170070 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cytocell, Ltd.

Sources (1)

  • FDA UDI 8a6d4114-599a-4479-bafb-30f2ecf91ec0 36 fields · synced May 30, 2026