Geneohm Sciences Canada Inc

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN (NQX) (5) Gastrointestinal pathogen panel multiplex nucleic acid-based assay system (PCH) (2) real time Nucleic acid amplification system (OOI) (2) Gastrointestinal bacterial panel multiplex nucleic acid-based assay system (PCI) (1) CLINICAL SAMPLE CONCENTRATOR (JJH) (1) SYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, ENTEROCOCCUS SPECIES (NIJ) (1) Trichomonas vaginalis nucleic acid amplification test system (OUY) (1)

Premarket Exempt

No Yes

Clear

BD MAX™ RNA-3 - 00382904375065 Catalog Number : 437506

Device Description : BD MAX™ RNA-3

Device Class : 1

Duns Number: 255438483

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

BD GeneOhm™ StaphSR assay 48 TestsA - 00382904414481 Catalog Number : 441448

Device Description : Kit BD GeneOhm StaphSR 48 USA

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

BD GeneOhm™ MRSA ACP Assay (48 tests) - 00382904416379 Catalog Number : 441637

Device Description : BD GeneOhm™ MRSA ACP Assay (48 tests)

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

BD GeneOhm™ MRSA ACP Lysis Kit - 00382904416386 Catalog Number : 441638

Device Description : BD GeneOhm™ MRSA ACP Lysis Kit

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

BD GeneOhm™ MRSA ACP Assay - 00382904416393 Catalog Number : 441639

Device Description : BD GeneOhm™ MRSA ACP Assay (200 tests)

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

BD GeneOhm™ VanR Assay - 00382904416652 Catalog Number : 441665

Device Description : BD GeneOhm™ VanR Assay 200 Tests

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : NIJ

Prescription Use : Yes

Device Count : 1

BD MAX™ MRSA - 00382904429539 Catalog Number : 442953

Device Description : BD MAX™ MRSA

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

BD MAX™ Enteric Bacterial Panel (US/CAN) - 00382904433789 Catalog Number : 443378

Device Description : Kit BD Max Enteric Bacterial Panel USA

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : PCH, PCI, OOI

Prescription Use : Yes

Device Count : 1

BD MAX™ Enteric Parasite Panel (US/CAN) - 00382904433802 Catalog Number : 443380

Device Description : BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction T BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : PCH, OOI

Prescription Use : Yes

Device Count : 1

BD MAX™ CT/GC/TV - 00382904438241 Catalog Number : 443824

Device Description : Kit BD Max CT/GC/TV US

Device Class : 2

Duns Number: 255438483

Premarket Exempt : No

Product Code : OUY

Prescription Use : Yes

Device Count : 1

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