BD Diagnostics EN

443419 24 tests BD MAX Staph SR - IVD Assay
The BD MAX StaphSR Assay performed on the BD MAX System is an
automated qualitative in vitro diagnostic test for the rapid detection of
Staphylococcus aureus (SA) DNA and methicillin-resistant Staphylococcus
aureus (MRSA) DNA from nasal swabs in patients at risk for nasal
colonization. The test utilizes real-time polymerase chain reaction (PCR)
for the amplification of specific DNA targets and fluorogenic targetspecific
hybridization probes to detect and differentiate MRSA and SA
DNA: specific amplicon in the SCCmec right-extremity junction (MREJ), the
genes for methicillin resistance mecA and mecC, the gene nuc encoding
a thermostable nuclease of S. aureus. The BD MAX StaphSR Assay is
intended to aid in the prevention and control of MRSA and SA in site
surgical infections (SSIs).
443461 24 tests BD MAX MRSA XT - IVD Assay
The BD MAX MRSA XT assay performed on the BD MAX System is
an automated qualitative in vitro diagnostic test for the direct detection
of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal
swabs in patients at risk for nasal colonization. The test utilizes real-time
polymerase chain reaction (PCR) for the amplification of MRSA DNA and
fluorogenic target-specific hybridization probes for the detection of the
amplified DNA: specific amplicon in the SCCmec right-extremity junction
(MREJ), the genes for methicillin resistance mecA and mecC, the gene nuc
encoding a thermostable nuclease of S. aureus. The BD MAX MRSA XT
assay is intended to aid in the prevention and control of MRSA infections in
healthcare settings.
443379 24 tests BD MAX CRE - RUO Assay
The BD MAX CRE Assay is a research use only (RUO) assay designed to
detect three antimicrobial resistance genes (KPC, OXA-48 and/or NDM)
found predominantly in carbapenem-resistant Enterobacteriaceae (CRE).
442963 24 tests BD MAX Enteric Bacterial Panel - IVD Assay
The BD MAX Enteric Bacterial Panel, as implemented on the BD MAX
System, is an automated in vitro diagnostic test for the direct qualitative
detection of enteric bacterial pathogens. Enteric bacterial targets include
Salmonella spp., Campylobacter spp. (jejuni and coli), Shigellosis disease
causing agents [Shigella spp. and Enteroinvasive E. coli (EIEC)] as well
as Shiga-toxin producing E. coli from unpreserved soft to diarrheal stool
specimen or Cary-Blair preserved stool specimens from symptomatic
patients with suspected acute gastroenteritis, enteritis or colitis. The test is
performed directly on the specimen, utilizing real-time polymerase chain
reaction (RT-PCR) for the amplification of SpaO, a Campylobacter specific tuf
gene sequence, ipaH, stx 1a and stx 2a. The test utilizes fluorogenic genespecific
hybridization probes for detection of the amplified DNA.
442960 24 tests BD MAX Enteric Parasite Panel - IVD Assay
The BD MAX Enteric Parasite Panel, as implemented on the BD MAX
System, is an automated in vitro diagnostic test for the direct qualitative
detection of enteric parasitic pathogens. Enteric parasite targets include
Giardia lamblia, Cryptosporidium (C. hominis and C. parvum), and
Entamoeba histolytica from unpreserved or formalin-fixed stool specimens
from symptomatic patients with suspected gastroenteritis and/or colitis.
The assay is intended to aid in the diagnosis of gastrointestinal infection
when used in conjunction with clinical evaluation and other laboratory
findings. The test is performed directly on the specimen, utilizing real-time
polymerase chain reaction (qPCR) for the amplification of specific targets.
The test utilizes fluorogenic gene-specific hybridization probes for detection
of the amplified DNA.
441772 24 tests BD MAX GBS - IVD Assay
The BD MAX GBS Assay as implemented on the BD MAX System is a
qualitative in vitro diagnostic test designed to detect Group B Streptococcus
(GBS) DNA in Lim Broth cultures, after incubation for greater than or equal
to 18 hours, obtained from vaginal-rectal swab specimens from antepartum
pregnant women. The test incorporates automated DNA extraction to
isolate the target nucleic acid from the specimen and real-time polymerase
chain reaction (PCR) to detect a 124 bp region of the cfb gene sequence
of the Streptococcus agalactiae chromosome. Results from the BD MAX
GBS Assay can be used as an aid in determining colonization status in
antepartum women.
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