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Dri-Scope Aid-Cabinet; Pump Wall BL1; Series 1840; DSAC-PW3-MOB; TRICOR Label;
Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. This pump component is used along with 2 (or 1) of the Dri-Scope Aid - Manifolds which together works as a drying system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software.
TRICOR SYSTEMS, INC.
DCPW-BL1-MOB
In Commercial Distribution
- 00810053600474 ()
DCPW-BL1-MOB
- Endoscope dryer
DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.
ILLUMINA, INC.
20006259
In Commercial Distribution
- 00816270020064 ()
20006259
- Nucleic acid sequencing reagent kit IVD
DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.
ILLUMINA, INC.
20005718
In Commercial Distribution
- 00816270020057 ()
20005718
- Nucleic acid sequencing reagent kit IVD
Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actions
performed and the user prompts.
The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.
Spectral Medical Inc
84007
In Commercial Distribution
- B173840070 ()
- Not Applicable
84007
- Multiple clinical chemistry analyser IVD, laboratory
The Heidelberg pH Capsule system is an assembly of devices designed to continuously monitor, measures and transmit information from the gastric and gastrointestinal systems. The transmitted gastric and gastrointestinal parameters from the pH Capsule are (i.e., pH or events), (e.g., gastric bleeding). The information from the pH capsule is received by the transceiver and then sent through the interface and to the computer. The computer software analyzes the information and displays it on a generated graph. The system assembly includes various solutions, test tubes, fluid containers and pH capsule calibration test fixture. The Heidelberg pH Capsule System is intended to help diagnose varies gastric and gastrointestinal pH related disorders.
Heidelberg Medical Inc
Heidelberg pH Capsule System
In Commercial Distribution
- B989HPHDS180 ()
HPHDS18
- Gastrointestinal telemetric monitoring system
Dri-Scope Aid-Cabinet; Pump Wall BL1; Series 1840; DSAC-PW3-MOB-R; TRICOR Label; Refurbished;
Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. This pump component is used along with 2 (or 1) of the Dri-Scope Aid - Manifolds which together works as a drying system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software. This component has been refurbished to a condition of safety and effectiveness that is comparable to when new.
TRICOR SYSTEMS, INC.
DCPW-BL1-MOB
In Commercial Distribution
- 00810053600573 ()
DCPW-BL1-MOB
- Endoscope dryer
The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software.
The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles.
ILLUMINA, INC.
20028870
In Commercial Distribution
- 00816270020132 ()
20028870
- Nucleic acid sequencing reagent kit IVD
MagXtract 3200 Automated Nucleic Acid Extraction System
The MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes.
Product Use Limitations:
The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments.
CHROMA ATE INC.
MagXtract 3200
In Commercial Distribution
- 04719889100010 ()
- Magnetic particle separation instrument IVD
RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 32 instrument is designed for use by laboratory professionals.
RADI EXTRACTOR 32 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System.
KH Medical Co., Ltd.
OE005
In Commercial Distribution
- 08800204300133 ()
- Nucleic acid sample preparation instrument IVD
RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 192 instrument is designed for use by laboratory professionals.
RADI EXTRACTOR 192 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System.
KH Medical Co., Ltd.
OE006
In Commercial Distribution
- 08800204300027 ()
- Nucleic acid sample preparation instrument IVD