ROMA Calculation Tool Using Elecsys Assay 07113358001

GUDID 00365702702127

Roche Diagnostics GmbH

Medical equipment clinical data interfacing software
Primary Device ID00365702702127
NIH Device Record Keydc4533b4-1c65-4f8a-97f2-44ea0a9a8d6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameROMA Calculation Tool Using Elecsys Assay
Version Model Number07113358001
Catalog Number07113358001
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100365702702127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONXovarian adnexal mass assessment score test system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-10-28

Devices Manufactured by Roche Diagnostics GmbH

04015630037025 - cobas b 123 Fluid Pack 4002024-08-07
04015630037032 - cobas b 123 Fluid Pack 7002024-08-07
04015630037049 - cobas b 123 Fluid Pack 2002024-08-07
04015630037636 - cobas b 123 Fluid Pack COOX 2002024-08-07
04015630037643 - cobas b 123 Fluid Pack COOX 4002024-08-07
04015630037650 - cobas b 123 Fluid Pack COOX 7002024-08-07
07613336170304 - Elecsys PTH2024-08-07 E2G 300 count
07613336170311 - CalSet PTH2024-08-07

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