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No Description
Roche Molecular Systems, Inc.
03279332001
In Commercial Distribution
- 04015630924745 ()
03279332001
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
MERIDIAN BIOSCIENCE, INC.
610210
In Commercial Distribution
- 00840733102318 ()
610210
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
Curetis GmbH
Curetis Qualified QuantStudio™ 5 Real-Time PCR System
62006
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument to process 2 Unyvero Cartridges
Curetis GmbH
A50 Analyzer
Not in Commercial Distribution
- 04260364750003 ()
60001
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation.
ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay
ELITECHGROUP SPA
INT030-K
In Commercial Distribution
- 03661540900006 ()
INT030-K
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus Deepwell Dx
BIO-RAD LABORATORIES, INC.
12016687
In Commercial Distribution
- 03610522260829 ()
- 1 ea
12016687
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 384 Dx
BIO-RAD LABORATORIES, INC.
12014335
In Commercial Distribution
- 03610522203437 ()
- 1 each
12014335
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 96 Dx
BIO-RAD LABORATORIES, INC.
12014330
In Commercial Distribution
- 03610522203413 ()
- 1 each
12014330
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1844095-IVD
In Commercial Distribution
- 03610520550984 ()
1844095-IVD
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1845097-IVD
In Commercial Distribution
- 03610520457818 ()
1845097-IVD
- Thermal cycler nucleic acid amplification analyser IVD, laboratory