NQX

Product Code: NQX


Products Classified as NQX

3515System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenAntimicrobial Susceptibility Test Powder.

Total Product Life Cycle (TPLC) Devices

3515System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenAntimicrobial Susceptibility Test Powder.

Pre-market Notifications for NQX

K191742ARIES MRSA AssayLuminex Corporation
K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid
K162444Xpert MRSA NxGCEPHEID
K142721Cobas MRSA/SA TestROCHE MOLECULAR SYSTEMS, INC.
K133605BD MAX MRSA XT, BD MAX INSTRUMENTGENEOHM SCIENCES CANADA, INC.
K132822BD MAX STAPHSR ASSAY, INSTRUMENTGENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
K132468MRSA/SA ELITE MGB, ELITE MGB SOFTWAREELITechGroup Epoch Biosciences
K130894XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENECEPHEID
K120138BD MAX MRSA ASSAY, BD MAX INSTRUMENTBD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
K112937MRSA/SA ELITE MGBELITECH
K112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)NANOSPHERE, INC
K102740NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6BIOMERIEUX, INC.
K101879XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10CEPHEID
K100822XPERT MRSA/SA NASAL ASSAYCEPHEID
K093346BD GENEOHM MRSA ACP ASSAYBD DIAGNOSTICS (GENEOHM SCIENCES, INC.)

Global Unique Device Identification Database

00382904434618SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00382904429539SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00382904416393SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00382904416386SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00382904416379SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00382904414481SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00875197004427SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00875197002997SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00875197002973SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
00857573006287System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
00857573006218System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
00857573006119System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
07332940002442System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
07332940001728System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
07332940001711System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Maude Adverse Events

XPERT MTB/RIFCEPHEID2018-05-26
XPERT MRSA/SA BCCEPHEID2018-03-28
BD MAX? STAPHSRGENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)2017-12-28
COBAS MRSA/SA TEST FOR USE ON THE COBAS 4800 SYSTEMROCHE MOLECULAR SYSTEMS2015-05-13
BD MAX MRSA ASSAYBD2015-02-23
BD MAX STAPHSRGENEOHM SCIENCES CANADA INC. (BD DIAGNOSTICS)2015-02-23
GENEXPERT XPERT MRSACEPHEID2012-09-21
XPERT MRSA/SA BCCEPHEID2010-05-04
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