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Ion Torrent Genexus Dx Software

FDA UDI

Class II (US FDA UDI)

by Life Technologies Holdings Pte. Ltd.

Identity

Trade Name
Ion Torrent Genexus Dx Software FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
Ion Torrent Genexus Dx Software FDA UDI
Model / Reference
6.8 FDA UDI
Description
Ion Torrent Genexus Dx Software FDA UDI

Identifiers

Catalog Number
A56332 FDA UDI
Primary DI / UDI-DI
10190302018883 FDA UDI
FDA Product Code
PFF FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2265 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

Ion Torrent Genexus Dx Software by Life Technologies Holdings Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Life Technologies Holdings Pte. Ltd.

Sources (1)

  • FDA UDI 679dadb1-3cf0-42b8-8093-da24d8e00705 34 fields · synced May 30, 2026