site stats

Simplexa vzv swab direct package insert

WebbOur Simplexa ® VZV Swab Direct assay utilizes only 50 µl of cutaneous or mucocutaneous swab specimen. Broad coverage includes samples collected from lesion locations … WebbThe Simplexa ® VZV Direct assay demonstrated high performance with excellent clinical agreement against PCR/bi-directional sequencing for both prospective and contrived …

Simplexa™ VZV Swab Direct Kit - DiaSorin Molecular

WebbThe Solana HSV 1+2/VZV Assay is a multiplex in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), and Varicella-zoster virus (VZV) … Webb30 aug. 2024 · The DiaSorin Molecular Simplexa™ COVID-19 Direct assay system is a real-time RT-PCR system that en ables the direct amplification of Coronavirus SARS-CoV-2 RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal wash/aspirate (NW) or bronchoalveolar lavage (BAL) specimens. fix waffle maker https://departmentfortyfour.com

510(k) Substantial Equivalence Determination Decision …

WebbThe Simplexa™ VZV Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplificationand detection of VZV DNA from unprocessed … WebbThe DiaSorin Simplexa™ Varicella Zoster Virus (VZV) Direct FDA approved assay is a rapid real-time PCR that enables the direct amplification, detection of VZV from both cutaneous and mucocutaneous swab specimens and CSF specimens. A well conserved region of the VZV DNA polymerase gene is targeted to identify VZV in the specimen. WebbThe Simplexa™ HSV 1/2 & VZV Universal Direct assay demonstrated greater than 98% positive percent agreement and greater than or equal to 99.0% negative percent … cannock bowls league fixtures

Poster Abstracts

Category:510(k) Premarket Notification

Tags:Simplexa vzv swab direct package insert

Simplexa vzv swab direct package insert

Kit Archive - DiaSorin Molecular

WebbOur Simplexa ® HSV 1 & 2 Direct assay utilizes only 50 µl of sample and is cleared for BOTH CSF and mucocutaneous/cutaneous swabs. Broad coverage that includes samples collected from lesion locations … Webbassay, DiaSorin Molecular Simplexa™ VZV Swab Direct assay, and Quest Diagnostics Inc. laboratory developed test (LDT). Composite comparator analysis was used to determine the sensitivity and specificity of the Alinity m assay. Results: Alinity m assay sensitivity was 97.7% (85/87; 95% CI of 92.0% - 99.4%) and

Simplexa vzv swab direct package insert

Did you know?

WebbOur Simplexa ™ VZV Swab Direct assay utilizes only 50 µl of cutaneous or mucocutaneous swab specimen. Broad coverage includes samples collected from lesion locations …

WebbDevice Classification Name. herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples. 22. 510 (k) Number. K192376. Device … WebbNeonatal surface swabs: Using a single regular flocked swab, swab conjunctivae, mouth, nasopharynx, and rectum. Break the swab into UTM and transport to the laboratory immediately. ... References: Simplexa HSV 1&2 Direct Package Insert. Rev. 04 ed. Cypress, CA: Diasorin Molecular 2024. p1-35 CLSI.

WebbDEVICE: Simplexa™ VZV Swab Direct (20816101025712) Download: XML JSON Print Device Record History View all sections Close all sections Device Identifier (DI) Information Brand Name: Simplexa™ VZV Swab Direct Version or Model: MOL3655 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company … WebbThe Simplexa® COVID-19 Direct has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. The test has been …

WebbOur Simplexa TM HSV 1 & 2 Direct assay utilizes only 50 µl of sample and is cleared for BOTH CSF and mucocutaneous/cutaneous swabs. Broad coverage that includes …

WebbThe Simplexa® COVID-19 Direct kit allows for fast results directly from nasal swab, nasopharyngeal swab, nasal wash/aspirate, and BAL specimens, eliminating traditional … cannock buildersWebbIn the Simplexa™ COVID-19 Direct assay, fluorescent p robes are used together with corresponding forward and reverse primers to amplify SARSCoV-2 viral RNA and internal … cannock brewersWebbThe Simplexa VZV Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of VZV DNA from unprocessed cerebral … cannock bowls leagueWebbThe Simplexa HSV 1 & 2 Direct assay system is a real-time PCR that enables the direct amplification, detection and differentiation of HSV-1 and/or HSV-2 DNA from … cannock boxingWebbThe Simplexa™ VZV Direct assay demonstrated high performance with excellent clinical agreement against PCR/bi-directional sequencing for CSF samples. Simplexa TM VZV … cannock bowling pavilionWebbSimplexa™VZV Swab Direct Kit Fast and Accurate VZV Testing A real-time PCR assay for the direct detection of varicella-zoster virus DNA from 50 μL of unprocessed cutaneous and mucocutaneous lesion swab specimens without nucleic acid extraction fix waiting for cacheWebbThe Simplexa VZV Swab Direct assay is a real-time PCR system that enables the direct amplification and detection of VZV DNA from unprocessed cutaneous and … fix waiting for any device