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The BD Veritor™ System for SARS-CoV-2 is a chromatographic digital immunoassay for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic). The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the BD Veritor™ System for SARS-CoV-2 and followed up with a molecular test. A negative test result is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established between April 2024 and August 2024 when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The BD Veritor™ System for SARS-CoV-2 is a rapid (approximately 15 minutes) chromatographic digital immunoassay for the direct detection of the presence or absence of SARS-CoV-2 antigens in anterior nasal swab specimens taken from patients with signs and symptoms of upper respiratory infection (i.e., symptomatic) who are suspected of COVID-19 by their healthcare provider. The test is intended for use with an opto-electronic interpretation instrument, the BD Veritor™ Plus Analyzer Instrument and is not interpreted visually. - When specimens are processed and added to the test device, SARS‑CoV‑2 antigens present in the specimen bind to biotinylated antibodies and antibodies conjugated to detector particles in the test strip. - The biotinylated antibody‑antigen‑conjugate complexes migrate across the test strip to the reaction area and are captured by a line of streptavidin bound on the membrane. - A positive result is determined by the BD Veritor™ Plus Analyzer when antigen‑conjugate is deposited at the Test "T" position and a control conjugate is deposited at the Control "C" position on the assay device. - The instrument analyzes and corrects for non‑specific binding and detects positives not recognized by the unaided eye to provide an objective result. Procedures to evaluate test devices depend on the BD Veritor™ Plus Analyzer workflow configuration chosen. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Additionally, connection of a BD Veritor™ Plus Analyzer to a printer or IT system is possible if desired. Additional result documentation capabilities are possible with the integration of a BD Veritor™ barcode scanning enabled module. The Analyzer uses a proprietary algorithm that subtracts the nonspecific signal at the negative control line from the signal present at the test line. If the resultant test line signal is above a preselected cutoff, the specimen is scored as positive. If the resultant test line signal is below or equal to the cutoff, the specimen is scored as negative. Use of the active negative control feature allows the BD Veritor™ Plus Analyzer to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The Analyzer measures the amount of light reflected from various zones along the assay strip. The measurement of the assay background zone is an important factor during the test interpretation as the reflectance value is compared to that of the control and test zones.

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacterales and Non-Enterobacterales and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This premarket notification is for the BD Phoenix Automated Microbiology System with Imipenem-relebactam at a concentration of 0.0625/4-16/4 µg/mL. Testing is indicated for Acinetobacter calcoaceticus-baumannii complex, Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) has demonstrated acceptable performance with the following organisms: - Acinetobacter calcoaceticus-baumannii complex - Enterobacterales (Citrobacter amalonaticus, Citrobacter braakii, Citrobacter farmeri, Citrobacter freundii, Citrobacter koseri, Citrobacter youngae, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, and Serratia marcescens) - Pseudomonas aeruginosa

The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 10^5 CFU/mL. The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 °C ± 1 °C. Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system. Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.

The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-positive bacteria from pure culture belonging to the genera Staphylococcus, other gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.

BD Phoenix is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The BD Phoenix System utilizes a redox indicator to detect organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations. The Phoenix instrument reads and records of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). The BDXpert™ System is a rule-based software tool that provides expert advice based on organism ID and AST results obtained by broth micro-dilution on the BD Phoenix Instruments. BDXpert rule development is based on published information available through standards organizations, current scientific literature, and FDA's STIC; custom rules may be user defined if desired. The BDXpert System rule logic is applied to the susceptible, intermediate, and resistant (SIR) result, which is based on the breakpoint table and interpretation rule set included either in the BDXpert System on the standalone Phoenix instruments or through the BDXpert System on the connected BD EpiCenter™ data management system (EpiCenter) or BD Synapsys™ Informatics Solution (Synapsys). The resulting instrument report contains information such as: MIC interpretation, BDXpert rules, special messaging, resistance markers, etc. The expert results can then be sent to the Laboratory Information System (LIS). Synapsys is a browser-based software platform operating in the clinical lab setting, offering secure connectivity and data storage, integrated workflows, and analytics tools. Synapsys consists of software servers operating the application and database, securely networked through a facility IT infrastructure to diagnostic instrumentation, external healthcare IT systems such as the LIS, and browser-enabled client devices for operating the system. Synapsys connects BD lab automation and diagnostic instruments to a common database and provides a single user interface to integrate laboratory workflows. Synapsys provides bi-directional communication with BD Phoenix and is able to process ID and AST results received from a BD Phoenix instrument. The system will automatically associate a known organism ID result, regardless of source, to any ID/AST or AST only Phoenix panel(s) that have the same accession/isolate number and lack an organism ID.

The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from: - · Bacterial vaginosis (BV) markers (Individual markers are not reported) - o Lactobacillus spp. (L. crispatus and L. jensenii) - o Gardnerella vaginalis - o Atopobium vaginae - o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) - o Megasphaera-1 - · Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups) o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) - o Candida glabrata - o Candida krusei - · Trichomonas vaginalis (TV) The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis. The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System. The BD MAX™ Vaginal Panel performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacterial vaginosis (qualitative results reported based on detection and of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from: - · Bacterial vaginosis markers (Individual markers not reported) - o Lactobacillus spp. (L. crispatus and L. jensenii) - o Gardnerella vaginalis - o Atopobium vaginae - o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) - o Megasphaera-1 - · Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups) - o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis) - o Candida glabrata - o Candida krusei - • Trichomonas vaginalis (TV) The assay may be used to detect BV, VVC, and/or TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD MAX™ Vaginal is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

The BD Vaginal Panel is an automated, qualitative in vitro diagnostic test for bacterial vaginosis markers. Candida species associated with vulyovaginal candidiasis, and Trichomonas vaginalis. From a single specimen, a vaginal swab collected from a patient who is symptomatic for vaginitis or vaginosis, the test provides qualitative (positive) results for the presence of the following conditions and/or organisms: - Bacterial vaginosis (based on detection of Lactobacillus spp. (L. crispatus and L. . jensenii), Gardnerella vaginalis, Atopobium vaginae, Bacterial Vaginosis Associated Bacteria-2, and Megasphaera-1) - Candida spp. (C. albicans, c. tropicalis, C. parapsilosis, and C. dubliniensis) . - Candida glabrata ● - Candida krusei ● - Trichomonas vaginalis ● The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System under the trade names BD MAX™ Vaginal Panel and BD Vaginal Panel, respectively. The assay previously provided results for all five targets for every specimen run, regardless of whether the ordering clinician desires evaluation of all reported conditions. After clearance of this 510(k) submission, BD will release updates to the BD MAX™ and BD COR ™ software to allow users the versatility to mask results, per specimen, based on the order received from the clinician. This change allows a laboratory to use the BD Vaginal Panel to test a specimen for an individual target group (BV, VVC, or TV) or any two of the three targeted conditions, in addition to the current configuration that reports all three conditions simultaneously.

The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with power injectors.

Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (< 30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection. Midline catheters, including the PowerGlide Pro, may be considered in patients with difficult IV access as clinically indicated.

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, and Streptococcus, This premarket notification is for the BD Phoenix™ Automated Microbiology System with Ciprofloxacin at a concentration of 0.0156-4 ug/mL. Ciprofloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.

This submission is for a range extension of a single antimicrobial cleared for use on BD Phoenix ID/AST or AST only panels. The ID portion of the ID/AST combination panel was not subject to review in this submission. The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 105 CFU/mL. The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 ℃ ± 1 ℃. Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system. Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.

BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices available with Sodium Fluoride/Potassium Oxalate or Sodium Fluoride/Na2EDTA. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and centrifugation of venous blood specimens as required for in vitro diagnostic testing. Plastic BD Vacutainer® Fluoride Blood Collection Tubes are used to collect whole blood for the generation of plasma samples. Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium FluoridePotassium Oxalate are used for glucose and lactate determinations. Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium Fluoride/Na2EDTA are used for glucose determinations.

The BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, Class II in vitro diagnostic medical devices regulated under 21 CFR § 862.1675 for blood specimen collection devices, and product code GIM for tubes, vacuum sample, with anticoagulant. The tubes are intended to be used in settings where venous blood samples would be collected by trained healthcare professionals for the collection, containment, preservation, transportation, and centrifugation of blood in a closed tube. BD Vacutainer® Fluoride Blood Collection Tubes are available in a plastic configuration containing various additive combinations in a blended powder mixture. The blended powder mixture contains sodium fluoride, which acts as an antiglycolytic agent. The plastic tube configurations also include various additives which provide an anticoagulated specimen when used according to the instructions for use. Tubes include a Gray color-coded BD Hemogard™ Closure indicative of the Fluoride additive. Tube stoppers are lubricated with silicone to facilitate stopper insertion.

The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper System (CA, sirius CA, or sirius one CA) for the qualitative identification of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens. The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the BD Kiestra ReadA Compact and Bruker MALDI Biotyper System (CA, sirius one CA) to aid in the diagnosis of bacterial and fungal infections.

The BD Kiestra™ IdentifA automates preparation of MALDI targets for the Bruker MALDI Biotyper® CA System, sirius CA system, and/or sirius one CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/lonization Time-of-Flight Mass Spectrometry (MALDI-TOF MS). The system comprises of the BD Kiestra™ IdentifA module (including the associated software and onboard nephelometers and pipetting system), formic acid and automation-compatible transfer vials (for HCCA matrix and Bacterial Test Standard (BTS), which are obtained directly from Bruker and manually transferred to the vials for use on the instrument), consumables (pipette tips and cuvette arrays for preparation of organism suspensions and fluid movement), and nephelometer calibration standards (McFarland standard vials for measuring turbidity of microbial suspensions). When identification of an organism growing on a culture medium plate is required, a technologist designates specific colonies for picking by the BD Kiestra™ IdentifA module using a digital image of the plate obtained using the BD Kiestra™ ReadA Compact module. The BD Kiestra™ IdentifA automatically suspends the designated colonized water and uses an onboard nephelometer to determine the resulting turbidity. The organism concentration is adjusted automatically by picking additional designated colonies or by appropriate dilution of the suspension to achieve a turbidity within a targeted range of McFarland values. Based on the final organism concentration, the BD Kiestra™ IdentifA pipets one or more aliquots of the microbial suspension onto a MALDI target (either reusable 48-spot or disposable 96-spot targets) and dries the spots at elevated temperature. The BD Kiestra™ IdentifA performs the extended Direct Transfer (eDT) Sample Preparation Procedure from Bruker whereby the instrument overlays the dried sample spot on the MALDI target with formic acid and matrix. The BD Kiestra™ IdentifA also spots the BTS used for quality control of MALDI-TOF MS organism identification. Once spots are dry, the technologist manually removes the target from the BD Kiestra™ IdentifA and loads it into the Bruker MALDI Biotyper® System for analysis. Information regarding the location of each sample and BTS on the targets and the associated MALDI-TOF MS results are transmitted between the BD Kiestra™ IdentifA and Bruker MALDI Biotyper® System via the Synapsys Informatics, the main software interface, and the BD Kiestra™ BeA, the data interface hub module that communicates with all the other modules including the BD Kiestra™ IdentifA. In addition to preparing the MALDI target, if requested, the BD Kiestra™ IdentifA will also dilute the organism suspension to a standardized turbidity of 0.5 McFarland. Modules of the BD Kiestra™ System each have their own operating software that communicates via the central BeA data interface hub module with the Synapsys user interface which in turn sends and receives information to/from the Laboratory Information System (LIS). The BD KiestraTM ReadA or ReadA Compact module is required for use in conjunction with the BD Kiestra™ IdentifA module for image capture. Culture plate incubation may be done offline and then moved to the BD Kiestra™ ReadA or ReadA Compact module for imaging, or incubation can be done in the ReadA and then remain in the ReadA for imaging. Additional software modules (BD Synapsys Informatics and BD Kiestra™ BeA) are also required for the function of the BD Kiestra™ IdentifA, and these modules reside on the BD Kiestra™ Laboratory Automation Solution. The digital image is used by the BD Kiestra™ IdentifA for image analysis and colony designation by the operator.

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.

0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe is a polypropylene syringe intended to flush indwelling vascular access devices. It is a sterile, single use syringe prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The device is packaged in a film-on-film blister pack and sterilized by gamma irradiation. External sterility of the device enables it to be used in the sterile field. The subject device is available only in 10mL syringe configuration.

BD BBL Sensi-Disc Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. BD BBL Sensi-Disc Lefamulin Disc 20 µg (LMU-20) can be used to determine susceptibility to Lefamulin against the following bacteria, as described in the FDA-approved package insert for this antimicrobial agent. Active in vitro and in Clinical Infections Against: Gram-positive Bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates) Gram-negative Bacteria Haemophilus influenzae

The BD BBL Sensi-Disc Lefamulin 20 µg (LMU-20) device is a 6 mm disc prepared by impregnating high quality absorbent paper with accurately determined amounts of Lefamulin. Discs are clearly marked on both sides with the code LMU-20. The code designates the agent Lefamulin (LMU) and the drug content (20 ug). BD BBL Sensi-Disc Antimicrobial Susceptibility Test Discs are furnished in cartridges containing 50 discs each. The last disc in each cartridge is marked "X" and contains the drug as coded. BD BBL Sensi-Disc Antimicrobial Susceptibility Test Discs can be dispensed using a BD BBL Sensi-Disc Dispenser.