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OncoMate 5C Matrix Standard

FDA UDI

Class II (US FDA UDI)

by Promega Corporation

Identity

Trade Name
OncoMate 5C Matrix Standard FDA UDI
Generic Name
Microsatellite instability IVD, reagent FDA UDI
Device Name
Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Analyzer to generate a multicomponent matrix that is applied during the subsequent analysis of amplification products from the OncoMate™ MSI Dx Analysis System. FDA UDI
Model / Reference
MD4850 FDA UDI
Description
Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Analyzer to generate a multicomponent matrix that is applied during the subsequent analysis of amplification products from the OncoMate™ MSI Dx Analysis System. FDA UDI

Identifiers

Catalog Number
MD4850 FDA UDI
Primary DI / UDI-DI
00849811050619 FDA UDI
FDA Product Code
PZJ FDA UDI
GMDN Term
Microsatellite instability IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.1866 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Microsatellite instability IVD, reagent

OncoMate 5C Matrix Standard by Promega Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Promega Corporation

Sources (1)

  • FDA UDI 3bc0f50a-e636-4542-8177-cdc02a8a1b8d 34 fields · synced Jun 9, 2026