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Oncomine™ Dx Target Test User Guides and Assay Definition File

FDA UDIEUDAMED

Class III (US FDA UDI)

by Life Technologies Limited

Identity

Trade Name
Oncomine™ Dx Target Test User Guides and Assay Definition File FDA UDI
Generic Name
Human genomic analysis interpretive software FDA UDI
Device Name
ODXTT UG & ADF V10.0 USB - USA FDA UDI
Model / Reference
A51694 FDA UDI
Description
ODXTT UG & ADF V10.0 USB - USA FDA UDI

Identifiers

Primary DI / UDI-DI
10190302017756 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 Guides and Assay Definition File by Life Technologies Limited — Class III — IVDR, IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Human genomic analysis interpretive software.

Cleared under the same submission

P160045 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Life Technologies Limited

Sources (2)

  • FDA UDI 4eeeae86-e1de-4a5c-9876-35576867e8dc 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026