FDA.reportPublic FDA data

THxID™-BRAF

Primary DI
03573026354909
Brand
THxID™-BRAF
Company
BIOMERIEUX SA
Model
410697
Device description
The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue
Published
2014-09-23
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
P120014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120014000BIOMERIEUX THXID BRAF ASSAY KITbioMerieux, Inc.2013-05-29OWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026354909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026354909035730263549093573026354909

GMDN Terms#

Term, Definition table
TermDefinition
BRAF V600 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 V600 mutation status of the BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene e.g., (V600A, V600D, V600E, V600K and V600R) in tumour tissue, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
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03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00054749005505i-STATABBOTT POINT OF CARE INC.OWD2020-10-05
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00054749005123i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
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00054749005529i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
04053228035725therascreen® BRAF RGQ PCR KitQIAGEN GmbHOWD2020-06-11
00850052003739LeukoStratINVIVOSCRIBE, INC.OWD2020-06-08
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00054749005512i-STATABBOTT POINT OF CARE INC.OWD2020-05-01
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04053228034223therascreen® PIK3CA RGQ PCR KitQIAGEN GmbHOWD2019-06-05
04053228034094therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2019-04-29
00884999047792RealTimeABBOTT MOLECULAR INC.OWD2018-08-06
00884999047341RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
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