FDA.reportPublic FDA data

GeneOhm Sciences Canada, ULC.

Matched from indexed company URL: GENEOHM SCIENCES CANADA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30074208753007420875GeneOhm Sciences Canada, ULC.1N2026-01-012555 Boul. du Parc-Technologique Quebec CA G1P 4S5

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00382904375065BD MAX™ RNA-3 - 437506+1(800)638-8663Technical_services@bd.com
00382904414481BD GeneOhm™ StaphSR assay 48 TestsA - Kit BD GeneOhm StaphSR 48 USA+1(800)638-8663Technical_services@bd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
966641586945969K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR SystemPCI2025-10-31
966641633588582K243343BD CTGCTV2QEP2025-04-22
966641351006948K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemQOF2023-07-31
966641223124877K223653BD Vaginal PanelPQA2023-03-06
966641340190007K220607BD MAX Enteric Viral PanelPCH2022-09-21
966641573556159K220193BD MAX Enteric Parasite PanelPCH2022-08-19
966641392029417K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelPCI2022-07-28
966641233837644K210585BD CTGCTV2QEP2022-05-10
966641859088861K201017BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitPQA2021-10-18
966641189428745K191957BD MAX Vaginal PanelPQA2019-10-21
966641530383166K190613BD MAX Check-Points CPOPOC2019-08-29
966641450142591K182692BD MAX CTGCTV2, BD MAX SystemOUY2019-01-08
966641813819089K181427BD MAX Enteric Viral Panel, BD MAX InstrumentPCH2018-11-29
966642021409598K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemPCH2017-05-02
966641338818134K151589BD MAX CT/GC/TV, BD MAX INSTRUMENTOUY2016-09-06
966641529851685K143648BD MAX Enteric Parasite Panel, BD MAX InstrumentPCH2015-08-25
966642009093956K140111BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENTPCI2014-05-06
966641630581384K133605BD MAX MRSA XT, BD MAX INSTRUMENTNQX2013-12-20
966641206651993K132822BD MAX STAPHSR ASSAY, INSTRUMENTNQX2013-11-26
966641515387896K130470BD MAX CDIFF ASSAY, BD MAX INSTRUMENTOZN2013-04-02
966641072776064K120138BD MAX MRSA ASSAY, BD MAX INSTRUMENTNQX2012-07-05
966641922516540K111860BD MAX GBS ASSAY, BD MAX INSTRUMENTNJR2012-02-16
966641366496935K090191HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLABNJR2010-05-27
966641484836135K081825BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAYLSL2008-12-11
966641150403862DEN160001BD MAX Vaginal Panel, BD MAX InstrumentPQA2016-10-28
966641071354469
966641456867573
966641503560705

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PCH52022-09-21
PQA42023-03-06
PCI32025-10-31
NQX32013-12-20
QEP22025-04-22
OUY22019-01-08
NJR22012-02-16
QOF12023-07-31
POC12019-08-29
OZN12013-04-02
LSL12008-12-11

PMN#

GUDID#