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OncoMate MSI Dx Interpretive Software

FDA UDI

Class II (US FDA UDI)

by Promega Corporation

Identity

Trade Name
OncoMate MSI Dx Interpretive Software FDA UDI
Generic Name
Microsatellite instability IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Software used to interpret data obtained using the OncoMate MSI Dx Analysis System. FDA UDI
Model / Reference
MD4140 FDA UDI
Description
Software used to interpret data obtained using the OncoMate MSI Dx Analysis System. FDA UDI

Identifiers

Catalog Number
MD4140 FDA UDI
Primary DI / UDI-DI
00849811056857 FDA UDI
510(k) Number
K200129 FDA UDI
FDA Product Code
PZJ FDA UDI
GMDN Term
Microsatellite instability IVD, kit, nucleic acid technique (NAT) 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

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: Microsatellite instability IVD, kit, nucleic acid technique (NAT)

OncoMate MSI Dx Interpretive Software by Promega Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microsatellite instability IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

K200129 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Promega Corporation

Sources (1)

  • FDA UDI 887f41bc-636d-4410-a0c8-eaea0fab0071 35 fields · synced Jun 9, 2026