Search Results

The Sensitite HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititire 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 the addition of Telavancin in the dilution range of 0.001-2μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 -24 hour MIC panel in the dilution range of 0.03-16μg/ml for testing Gram positive isolates, The approved primary "Indications for Use" and clinical significance of Telavancin is for: Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermidius, and S. constellatus) In vitro data, without clinical correlation is provided for: Facultative Gram-Positive Microorganisms: Enterococcus faecium (vancomycin-susceptible Isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp, equisimilis Staphylococcus epidermidis

Not Found

The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for caspofungin in the dilution range of 0.008 - 16ug/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of caspofungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Not Found

The "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for addition of Doxycycline in the dilution range of 0.03 - 16μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Doxycycline is for: Aerobic and facultative Gram-negative and Gram-positive microorganisms: Escherichia coli Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Streptococcus pyogenes Enterococcus spp. (faecalis and faecium) Staphylococcus aureus* *Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Not Found

The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for voriconazole in the dilution range of 0.008 - 16μg/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of voriconazole is for: Candida albicans Candida krusei Candida parapsilosis Candida tropicalis

Not Found

The Sensititre Vizion is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae.

The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the presence or absence of growth in the wells. The "Vizion" can be used as an alternate method where the user manually read the MIC result on the Sensititre System.

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of: "Dtest". The Dtest for Broth Microdilution Test is for Staphylococcus spp. resistant to (MIC's ≥ 8ug/ml) erythromycin and susceptible or intermediate (MIC's < 2ug/ml) to clindamycin. With these isolates a Dtest 1 (4/0.5 ug/ml) or 2 (8/1.5 ug/ml) or both 1 and 2 are positive (growth) the test should be reported as inducible clindamycin resistance. If with these isolates there is no growth in both Dtest 1 and 2 the isolates should be reported as negative for inducible resistance.

Not Found

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of: "Cefoxitin Screen". The "Cefoxitin Screen ( 6ug/ml) " can be used to predict the presence of mecAmediated resistance in Staphylococcus aureus. Isolates for which cefoxitin MIC tests > 6 (positive growth) should be reported as oxacillin resistant. Those which have cefoxitin MIC's of <= 6 (no growth) should be reported as oxacillin susceptible.

Not Found

The Sensititre® Haemophilus influenzae/Streptococcus species plates are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus species and manually with H.influenzae. This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32pg/mL) for use with the Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Daptomycin is for: Aerobic facultative Gram-positive microorganisms Streptococcus agalactiae Streptococcus pyogenes Streptococcus dysgalactiae subsp. equisimilis

Not Found

The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

Not Found