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Product Description
FLUXERGY TEST KIT COVID-19 Specifications:
Test Type : T-PCR, Direct
Time to Result : ~60 minutes
Sample Preparation : ~3 min from reagent thaw, No extraction required
Sample Type : NPS in 3mL VTM, See accepted VTMs*
Required Sample Volume : 14µL
Storage Condition : Fluxergy Card COVID-19: 10° to 30°C Fluxergy Reaction Mix COVID-19: -10° to -30°C
Gene Targets : Orf1ab polyprotein and N gene; Detects B.1.351 and B.1.1.7. variants (does not differentiate)
LOD* : 0.89 TCID50/mL
Platform Specifications :
Analyzer Size : 26.19 cm x 13.13 cm x 25.80 cm
Analyzer Weight : 6.8 kg
Power Input : 12V DC, 7A
Operating Temperature : 15°C – 30°C
Storage Temperature : 15°C – 30°C
Operating Humidity : 10%-85%
Recommended Computer Requirements : Operating System: OS must be 64-bit, Windows 10 v1151 or later
Processor: Intel Core i5 2.5GHz or equivalent Ram: 8GB DDR4 HDD: 250GB
Screen: 1080p
USB: 2x2.0 port (for scanner and mouse)
Networking: Ethernet port
Data Analysis Tools : Qualitative Result Interpretation
Fluxergy has obtained CE marking for its one-hour COVID-19RT-PCR test, to use by healthcare professionals as an in vitro diagnostics (IVD) for the detection of SARS-CoV-2. The CE-mark will allow Fluxergy’s innovative testing platform to enter the European Union market and any other markets that accept CE-marking as valid regulatory approval.
In December 2020, Fluxergy received dual ISO-1 3485:201 6 and MDSAP certifications. ISO 1 3485:201 6 is the medical device industry’s most widely used international standard for quality management systems to design, develop, produce, and deliver products. MDSAP certification satisfies the quality system requirements of the regulatory authorities participating in the program, including the U.S. Food and Drug Administration (FDA), Health Canada, Brazil’s Agência Nacional de Vigilância Sanitária and Australia’s Therapeutic Goods Administration.
In addition to exploring saliva/throat/nasal swab sample types for our existing COVID-19 test, we are also developing tests that can utilize Fluxergy’s first-of-its-kind multimodal technology. We are designing the following tests for the existing Fluxergy Analyzer model. Our product development pipeline includes:
