Test Impedance Tool

FDA UDI

Class II (US FDA UDI)

by Scibase AB

Identity

Trade Name: Test Impedance Tool FDA UDI
Generic Name: Neoplasm electrical impedance spectrometer FDA UDI
Device Name: The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measurement accuracy test should be performed once a month, to ensure that all Nevisense examinations will present correct measurement data. FDA UDI
Model / Reference: 590-0002 FDA UDI
Description: The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measurement accuracy test should be performed once a month, to ensure that all Nevisense examinations will present correct measurement data. FDA UDI

Identifiers

Catalog Number: 590-0002 FDA UDI
Primary DI / UDI-DI: 07350094440101 FDA UDI
PMA Number: P150046 FDA UDI
FDA Product Code: ONV FDA UDI
GMDN Term: Neoplasm electrical impedance spectrometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Neoplasm electrical impedance spectrometer

Test Impedance Tool by Scibase AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neoplasm electrical impedance spectrometer.

Control Unit Battery — Scibase AB · Class II
Probe cable — Scibase AB · Class II
Nevisense — Scibase AB · Class II
Probe unit — Scibase AB · Class II

Cleared under the same submission

P150046 also covers:

Control Unit Battery — Scibase AB
NeviFile kit US — Scibase AB
Nevisense — Scibase AB
Probe cable — Scibase AB
Probe unit — Scibase AB
Single Use Electrodes Sterile - 6 pcs — Scibase AB
Training electrode Sterile - 6 pcs — Scibase AB

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: Scibase AB

Sources (1)

FDA UDI 954f440d-4a9b-457a-9d18-fcbf69d550b2 35 fields · synced Jun 8, 2026