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Oncomine™ Dx Target Test

FDA UDI

Class III (US FDA UDI)

by Life Technologies Limited

Identity

Trade Name
Oncomine™ Dx Target Test FDA UDI
Generic Name
Multiple tissue-associated protein/tumour marker IVD, reagent FDA UDI
Device Name
ONC UNIV DX RNA/DNA PANEL IVD FDA UDI
Model / Reference
A32441 FDA UDI
Description
ONC UNIV DX RNA/DNA PANEL IVD FDA UDI

Identifiers

Primary DI / UDI-DI
10190302006385 FDA UDI
PMA Number
P160045 FDA UDI
FDA Product Code
PQP FDA UDI
GMDN Term
Multiple tissue-associated protein/tumour marker IVD, reagent FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Oncomine™ Dx Target Test by Life Technologies Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 6d0fab78-a58c-4663-b4cd-7fe1f9f68b2a 35 fields · synced May 30, 2026