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BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when veast or fungi are suspected.

BD BACTEC Myco/F Lytic culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens, and yeast and fungi from blood and sterile body fluids. Specific modifications were made to enhance the growth and recovery of mycobacteria, yeast and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent, and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism metabolism and growth. The sensor is monitored by the BD BACTEC fluorescent series instrument for increasing fluorescence, which is due to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial. BD BACTEC Myco/F Lytic Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTECTM fluorescent series instruments.

The BD BACTECTM Plus Aerobic/F Culture Vials contain a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood. It has been designed for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC™ fluorescent-series instruments in monitoring of clinical blood specimens for the presence of microorganisms. BD BACTECTM Plus Aerobic/F Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

The BACT/ALERT® MP Reagent System consists of the BACT/ALERT® MP culture bottle with a removable closure used in conjunction with the BACT/ALERT® MP Antimicrobial Supplement and the BACT/ALERT® MP Nutrient Supplement. The BACT/ALERT® MP Reagent System is designed for use with BACT/ALERT® 3D Mycobacteria Detection Systems for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested/decontaminated clinical specimens.

BACT/ALERT® MP Reagent System consists of three reagents: BACT/ALERT® MP Culture Bottle, the BACT/ALERT® MP Antimicrobial Supplement and the BACT/ALERT® MP Nutrient Supplement.

BacT/ALERT® FA Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood and other normally sterile body fluids. BacT/ALERT® PF Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood.

The BacT/ALERT® Microbial Detection Systems utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium. If microorganisms are present in the test sample, carbon dioxide is produced as the microorganisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2 the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The lighter color results in an increase of reflectance units monitored by the system. Bottle reflectance is monitored and recorded by the instrument every 10 minutes. BacT/ALERT® Microbial Detection Systems are used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremia/fungemia. The BacT/ALERT® Systems and culture bottles provide both a microbial detection system and a culture medium with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorqanisms that will grow in the BacT/ALERT® FA Plus or PF Plus Culture Bottle (The BacT/ALERT® PF Plus Culture Bottle provides for detection of microorganisms when a small volume of blood is available.).

The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs). The 216Dx System is not intended to provide bacteriuria levels, bacterial identification, or differentiation. The system does not distinguish between growth of infecting, colonizing or contaminating bacteria, or if mixed urogenital flora are present. Presumptive positive urine samples must be cultured. Presumptive negative urine samples must be cultured if a low level of bacteriuria is suspected and is clinically relevant. The system also does not detect anaerobic bacteria, fungi/yeasts, fastidious organisms or those associated with sterile pyuria.

The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs). The BacterioScan 216Dx System uses laser light scattering to measure turbidity (particle density) of a prepared urine-broth sample during a period of incubation. The system is designed to kinetically capture digital measurements of sample turbidity at very low particle densities. Classification software analyzes these optical signal measurements, and interprets increasing turbidity as bacterial growth. Samples with robust growth during the second half of the test cycle, and/or high turbidity, are reported as "Presumptive Positive" for bacteriuria and/or UTI. Low turbidity samples that do not exhibit growth are classified as "Presumptive Negative". The user logs into the 216Dx interface and is prompted to associate a patient sample ID with a Multicuvette serial number and well location. The user will then pipette the prepared liquid samples into a Multicuvette. Once the Multicuvette is filled, it is loaded into a 216Dx Instrument. The Multicuvette is then incubated for approximately three (3) hours. During the instrument run, the 216Dx appliance will analyze optical measurements to provide a qualitative determination of the presence or absence of viable bacteria in urine specimens at a cut-off of >5x10 CFU/ml. The Classification algorithm qualitatively assesses a result by analyzing periodic measurements taken throughout this incubation period.

BD BACTEC Peds Plus™F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 3 mL in volume.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor's fluorescence measurement is detected at regular intervals to determine the change in CO2 present in the system. A positive reading indicates the presumptive presence of viable microorganisms in the vial. BD BACTEC Peds Plus™F culture vial detection is limited to microorganisms that will grow in a particular type of medium.

BacT/ALERT® VIRTUO(TM) Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic microorganism growth from blood and other normally sterile body fluids.

The VIRTUO Instrument is the next generation of the bioMerieux BacT/ALERT Microbial Detection System. This blood culture instrument consists of an incubator, agitation mechanism, robotic apparatus for automated loading and unloading of bottles and a tactile graphical interface. The VIRTUO is used in conjunction with existing, commercialized BacT/ALERT reagent bottles for clinical use (BacT/ALERT SA, SN, FA Plus, FN Plus and PF Plus culture bottles). The VIRTUO system utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium. If microorganisms are present in the inoculated sample, carbon dioxide is produced as the organisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The color change results in an increase of reflectance units monitored by the system. The VIRTUO optically monitors the reflectance of each bottle over time and will store and interpret readings against algorithms, which are embedded in the firmware and/or software.

BD BACTECT™ Standard/10 Aerobic/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

BD BACTECTM Standard Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

BD BACTEC Peds Plus™/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 5 mL in volume.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.