OncoMate MSI Dx Interpretive Software MD4140

GUDID 00849811056857

Software used to interpret data obtained using the OncoMate MSI Dx Analysis System.

PROMEGA CORPORATION

Microsatellite instability IVD, kit, nucleic acid technique (NAT)
Primary Device ID00849811056857
NIH Device Record Key887f41bc-636d-4410-a0c8-eaea0fab0071
Commercial Distribution StatusIn Commercial Distribution
Brand NameOncoMate MSI Dx Interpretive Software
Version Model NumberMD4140
Catalog NumberMD4140
Company DUNS089855696
Company NamePROMEGA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849811056857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZJLynch Syndrome Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-08

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