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Oncomine™ Dx Target Test User Guide and Assay Definition File

FDA UDI

Class III (US FDA UDI)

by Life Technologies Limited

Identity

Trade Name
Oncomine™ Dx Target Test User Guide and Assay Definition File FDA UDI
Generic Name
Human genomic analysis interpretive software FDA UDI
Device Name
ODXTT UG & ADF V3.6 USB-US FDA UDI
Model / Reference
A49678 FDA UDI
Description
ODXTT UG & ADF V3.6 USB-US FDA UDI

Identifiers

Primary DI / UDI-DI
10190302015646 FDA UDI
PMA Number
P160045 FDA UDI
FDA Product Code
PQP FDA UDI
GMDN Term
Human genomic analysis interpretive software FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Human genomic analysis interpretive software

Oncomine™ Dx Target Test User Guide and Assay Definition File by Life Technologies Limited — Class III — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Human genomic analysis interpretive software.

Cleared under the same submission

P160045 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Life Technologies Limited

Sources (1)

  • FDA UDI f8c9a874-da13-4ed8-87df-da9226b37931 34 fields · synced May 31, 2026