navify POC Operations 10170280001

GUDID 07613336228623

Roche Diagnostics GmbH

Clinical laboratory information system application software
Primary Device ID07613336228623
NIH Device Record Key7d59e302-d5fe-4cd9-9b0d-3d606238d5d8
Commercial Distribution StatusIn Commercial Distribution
Brand Namenavify POC Operations
Version Model Number10170280001
Catalog Number10170280001
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS107613336228623 [Primary]

FDA Product Code

JQPCalculator/data processing module, for clinical use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

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07613336172124 - Elecsys PlGF2025-04-15
07613336220108 - PreciControl Rubella IgM2025-04-15
07613336230671 - Elecsys sFlT-12025-04-15
07613336230756 - Elecsys PlGF2025-04-15
07613336223321 - Kidney KFRE Algorithm2025-04-08

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