THxID™ BRAF

GUDID 03573026559823

Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)

BIOMERIEUX SA

BRAF gene mutation IVD, kit, nucleic acid technique (NAT)
Primary Device ID03573026559823
NIH Device Record Key5ab497ae-054a-494f-82f5-7bc9dcab444b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHxID™ BRAF
Version Model Number1.0
Company DUNS276816717
Company NameBIOMERIEUX SA
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026559823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWDSomatic Gene Mutation Detection System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-06-09
Device Publish Date2017-05-12

Devices Manufactured by BIOMERIEUX SA

03573026559823 - THxID™ BRAF2025-06-09Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)
03573026559823 - THxID™ BRAF2025-06-09 Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF
03573026637200 - VITEK® MS SOFTWARE v1.22025-05-07 The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems
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03573026359096 - VITEK® MS-DS2024-04-30 The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.
03573026359119 - VITEK® MS2024-04-29 MALDI-Tof Mass Spectrometry system used for microbial identification
03573026362843 - VITEK® MS FA2024-04-29 VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used e
03573026619527 - VIDAS® PC SOFTWARE V4.92024-04-29 VIDAS PC V4.9 W10 Software version for clinic
03573026256685 - ETEST® Gentamicin (GM)2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1

Trademark Results [THxID]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THXID
THXID
79121917 4366559 Live/Registered
bioMérieux
2012-10-10

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