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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 bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. 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) Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1 - Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) - Candida glabrata - Candida krusei - Trichomonas vaginalis The BD MAX 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 MAX System and the BD MAX Vaginal Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. For the BD MAX Vaginal Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

The BD MAX Vaginal Panel performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direction 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 Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. 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) Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1 - . Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) - Candida glabrata - Candida krusei - . Trichomonas vaginalis The BD MAX 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 MAX System and the BD MAX Vaginal Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. For the BD MAX Vaginal Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

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. The BD MAX™ MRSA XT assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor guide or monitor treatment for MRSA infections. A negative result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

The BD MAX™ System and the BD MAX™ MRSA XT assay are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. A test result may be called as MRSA NEG, MRSA POS or MRSA UNR (Unresolved)] based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.

The BD MAX™ StaphSR assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes realtime polymerase chain reaction (PCR) for the amplification of MRSA/SA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ StaphSR assay is intended to aid in the prevention and control of MRSA and SA infections in healthcare settings. It is not intended to diagnose MRSA or SA infections nor guide or monitor treatment for MRSA/SA infections. A negative result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

The BD MAX™ System and the BD MAX™ StaphSR assay are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. A test result may be called as [SA NEG MRSA NEG (negative)], [SA POS, MRSA POS (MRSA positive)], [SA POS, MRSA NEG (SA positive)] or [SA UNR, MRSA UNR (Unresolved)] based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.

The BD MAX™ Cdiff Assay performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having C. difficile infection (CDI). The test. performed directly on the specimen, utilizes real-time polymerase chain reaction (PCR) for the amplification of C. difficile toxin B gene DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX ™ Cdiff Assay is intended to aid in the diagnosis of CDI.

The BD MAX™ System and the BD MAX™ Cdiff Assay are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target Ivsis. DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test result may be called as NEG (negative), POS (positive) or UNR (unresolved) based on the amplification status of the target and of the Sample Processing Control. IND (indeterminate) or INC (incomplete) results are due to BD MAX™ System failure.

CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.

The CPI RAD VISION product will provide a user interface to control the digital imaging functions of a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images from a Solid State X-ray Imager (SSXI)). The CPI RAD VISION product will also provide either an option on the user interface to control the x-ray generator functions required by a radiographic acquisition modality or an optional hardware interface to allow the x-ray generator functions to be controlled by an independent third-party operator console while maintaining synchronization with the digital imaging functions of the product. CPI RAD VISION is a component of a complete radiographic x-ray system.

The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X-ray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems. The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities. The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION will not include the X-Ray system itself.

The CPI RAD VISION is a component of a complete radiographic x-ray system. The CPI RAD VISION provides a single user interface for control of the x-ray generator and all digital imaging functions required by a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images). The CPI RAD VISION consists of Flat Panel Detector, ISO-BOX (Medical Grade Isolation Transformer), LCD Monitor, and a workstation (computer) with x-ray generator interface, image receptor interface, and network port for communications with supported DICOM devices.

The IA ALIS device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnostic of alcohol intoxication.

The IA ALIS is a self-contained device that uses a semiconductor-based gas sensor and disposable straws for breath sampling and three 7-segment LED displays present the detected alcohol level. On the upper part of the screen there are fifteen lights for visual indication of the level of alcohol detected. The LED screen displays the user's blood alcohol equivalent concentration in two decimal places. On the bottom part of the screen there are four boxes for user instructions (step 1, step 2, step 3 and Wait). The device starts working when money is inserted into the machine. After the WAIT light goes on and the system performs a cleaning process, the BLOW light goes on and there is a beep when the device is ready to accept an air sample. As the user exhales with the straw into the hole, the device monitors the air pressure and blowing time. If the flow of the breath sample is sufficient, the indicator BLOW light goes from flashing to solid and the WAIT light goes on. Thereafter the system processes the air sample and gives a numerical result.

For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for: - abrasions - minor lacerations - minor cuts - minor scalds and burns Under the supervision of a healthcare professional, Algicelle Ag (Calcium Algiante Dressing with Antimicrobial Silver) dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wound such as: - diabetic foot ulcer - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology - pressure ulcers/sores (partial and full thickness) - donor sites, and traumatic and surgical wounds.

Calcium Alginate Dressing with Antimicrobial Silver is a primary wound dressing made of Calcium Alginate containing 1.4% Silver. In the presence of wound exudate, the sodium ions from the exudates take the place of the silver ions, releasing the silver ions. As wound exudate is absorbed, the alginate forms a gel, which assist in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions released in the presence of wound fluid protect the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The Sciences Derma Calcium Alginate Dressing with Antimicrobial Silver are sterile, single-use wound care dressings for use in moist wound management. This dressing is offered in several sizes including the following: 2"X2". 4.25"X4.25",4"X5",4"X8",8"X12".

Under the supervision of a healthcare professional, API-MED™ ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily exuding wounds such as: - diabetic foot ulcers . - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology) - pressure ulcers / sores (partial and full thickness) . - 1st and 2nd degree partial thickness burns . - donor sites, and traumatic and surgical wounds. .

Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing