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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) is for ciprofloxacin in the dilution range of 0.002-64 ug/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Enterobacterales and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage. The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL demonstrated acceptable performance with the following organisms: Enterobacterales (C. freundii, C. koseri, E. cloacae complex, E. coli, K. aerogenes, K. oxytoca, K.pneumoniae, M. morganii, P. mirabilis, P. rettgeri, P. stuartii, P. vulgaris, S. marcescens) Pseudomonas aeruginosa

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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for ceftobiprole in the dilution range of 0.008-16 µg/mL for testing fastidious isolates on the Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System. Testing is indicated for Streptococcus pneumoniae and Streptococcus pyogenes, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage. The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 µg/mL demonstrated acceptable performance with the following organisms: - Streptococcus pneumoniae - Streptococcus pyogenes

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ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non‑fastidious Gram‑negative and Gram‑positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Testing with ETEST® Aztreonam/Avibactam (AZA) (0.016/4-256/4 μg/mL) is indicated for Enterobacterales, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The ETEST® Aztreonam/Avibactam (AZA) (0.016/4-256/4 μg/mL) demonstrated acceptable performance with the following microorganisms: • **Enterobacterales:** - Escherichia coli - Klebsiella pneumoniae - Klebsiella aerogenes - Citrobacter freundii complex - Citrobacter koseri - Enterobacter cloacae complex - Proteus mirabilis - Proteus vulgaris - Morganella morganii - Providencia stuartii - Serratia marcescens

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in μg/mL on one side and a predefined antibiotic gradient on the other side. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of μg/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) contains a range of Aztreonam from (0.016-256 µg/mL), overlaid with a fixed concentration of 4 µg/mL of Avibactam.

NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production when grown on the following media: - 5% sheep blood agar or MacConkey agar (16-24 hours) - HardyCHROM™ ESBL agar (18-24 hours) The NG-Test® CTX-M MULTI is intended as an aid for infection control in the detection of CTX-M enzymes-producing organisms (Enterobacterales) in healthcare settings. NG-Test® CTX-M MULTI is not intended to guide or monitor treatment. A positive or negative NG-Test® CTX-M MULTI test result does not rule out the presence of other mechanisms of antibiotic resistance. NG-Test® CTX-M MULTI should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production after culturing on agar and processed in an extraction buffer. The device consists of a sample port, sample and conjugate pad, and nitrocellulose test strip, which are contained within a plastic cassette, in addition to reagents for liquid extraction. The result can be read 15 minutes after adding the sample to the sample well. A positive result on the NG-Test® CTX-M MULTI occurs when two red lines appear, one on the control (C) region and one on the test (T) region. A negative result occurs when only the control line is observed and indicates the sample does not contain any target CTX-M enzymes, or the CTX-M enzymes are present at a non-detectable level. If the control line does not appear, the test result is invalid. Monoclonal antibodies that recognize the five major CTX-M groups are immobilized on a nitrocellulose membrane. Free monoclonal antibodies are present in the conjugate pad and labeled with colloidal gold. Upon addition of the processed sample to the sample pad, the capillary action of the nitrocellulose draws the sample through the mobile antibodies in the conjugate pad and the immobile antibodies on the test strip. The immobilized control antibodies capture any mobile antibodies that do not bind to the test line.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) is for vancomycin in the dilution range of 0.25-128 ug/mL for testing non-fastidious gram-positive isolates on the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Staphylococcus aureus, Staphylococci other than Staphylococcus aureus, and Enterococcus spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage. The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL demonstrated acceptable performance with the following organisms: Staphylococcus aureus (including MRSA) Staphylococci other than Staphylococcus aureus (S. epidermidis, S. haemolyticus, S. hominis, S. lugdunensis, S. saprophyticus) Enterococcus spp. (E. faecalis, E. faecium)

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ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non fastidious Gram negative and Gram positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Testing with ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is indicated for Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) demonstrated acceptable performance with the following microorganism: • Pseudomonas aeruginosa

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in μg/mL on one side and a predefined antibiotic gradient on the other side. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of μg/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST Imipenem/Relebactam P. aeruginosa (IRPA) with a concentration range of 0.008/4-128/4 µg/mL is specially designed and formulated for testing P. aeruginosa.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) is for moxifloxacin in the dilution range of 0.008-16 µg/mL for testing non-fastidious gram-positive isolates on the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Staphylococcus spp. and Enterococcus faecalis, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage. The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 µg/mL demonstrated acceptable performance with the following organisms: - Staphylococcus spp. (S. aureus, S. epidermidis, S. haemolyticus, S. hominis, S. lugdunensis, and S. saprophyticus) - Enterococcus faecalis

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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for micafungin in the dilution range of 0.008-16 ug/mL for testing Candida spp. on The Sensitite YeastOne Susceptibility System. Micafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida guilliermondi Candida krusei Candida parapsilosis Candida tropicalis

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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for linezolid in the dilution range of 0.12-32 ug/mL for testing fastidious isolates on The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System. Linezolid has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Streptococcus spp. ß-hemolytic group (Streptococcus agalactiae, Streptococcus pyogenes) Linezolid has been shown to be active in vitro only against the following organisms according to the FDA drug label: Streptococcus spp. Viridans group

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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for penicillin in the dilution range of 0.015-32 ug/mL for testing fastidious isolates on The Sensitire 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System. Penicillin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Streptococus spp. ß-hemolytic group (Streptococus agalactiae, Streptococcus dysgalactiae, Streptococus pyogenes) Streptococcus spp. Viridans group

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