FDA.reportPublic FDA data

THxID™ BRAF

Primary DI
03573026559823
Brand
THxID™ BRAF
Company
BIOMERIEUX SA
Model
1.0
Device description
Software used in combination with the THxIDTM- BRAF assay(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)
Published
2017-05-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWDSomatic Gene Mutation Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWDSomatic Gene Mutation Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120014001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120014001BIOMERIEUX THXID BRAF ASSAY KITbioMerieux, Inc.2013-05-29OWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026559823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026559823035730265598233573026559823

GMDN Terms#

Term, Definition table
TermDefinition
BRAF gene mutation IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to select treatment options and/or monitor the response to cancer therapy by determining the mutation status of multiple regions of the BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene in tumour tissue, including codons 464 to 469 and 600, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1

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