Archive for month: March 2020

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Diagnostics

Date EUA Issued Manufacturer Diagnostic (Letter of Authorization) Fact Sheet for Healthcare Providers Fact Sheet for Patients Manufacturer Instructions / Package Insert Other Documents
03/27/2020 Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay Healthcare Providers Patients IFU None
03/26/2020 BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV Healthcare Providers Patients IFU None
03/25/2020 Avellino Lab USA, Inc. AvellinoCoV2 test Healthcare Providers Patients EUA Summary None
03/24/2020 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit Healthcare Providers Patients IFU None
03/23/2020 Mesa Biotech Inc. Accula SARS-Cov-2 Test Healthcare Providers Patients IFU None
03/23/2020 BioFire Defense, LLC BioFire COVID-19 Test Healthcare Providers Patients IFU None
03/20/2020 Cepheid Xpert Xpress SARS-CoV-2 test Healthcare Providers Patients IFU for Labs
IFU for Point-of-Care
None
03/20/2020 Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay Healthcare Providers Patients IFU None
03/19/2020 GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test Healthcare Providers Patients IFU None
03/19/2020 DiaSorin Molecular LLC Simplexa COVID-19 Direct assay Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 26, 2020)
03/18/2020 Abbott Molecular Abbott RealTime SARS-CoV-2 assay Healthcare Providers Patients IFU None
03/17/2020 Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 26, 2020)
03/17/2020 Quidel Corporation Lyra SARS-CoV-2 Assay Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 23, 2020)
03/16/2020 Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test Healthcare Providers Patients EUA
Summary
None
03/16/2020 Hologic, Inc. Panther Fusion SARS-CoV-2 Healthcare Providers Patients IFU None
03/13/2020 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 24, 2020)
03/12/2020 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2 Healthcare Providers Patients IFU None
02/29/2020 Wadsworth Center, New York State Department of Public Health’s (CDC) New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 15, 2020)
02/04/2020 Centers for Disease Control and Prevention’s (CDC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) Healthcare Providers Patients IFU None

 

KEPSA Launches Flowers Of Hope Campaign Under COVID-19 response

KEPSA Launches Flowers Of Hope Campaign Under COVID-19 response

KEPSA has today launched a campaign dubbed “Flowers of Hope” under its Economic Framework for COVID 19 response. The campaign will be implemented through KEPSA members as follows: Kenya Flower Council (KFC), Kenya Association of Manufacturers (KAM), Elgon Kenya, Kenya Airways and Jambo Jet and partners of KEPSA as volunteers from Rotary Kenya and women of Kenya initiative.

The flower farmers gave flowers to hospitals so that they don’t waste in the farms with less demand in buying both locally and internationally. This way, they keep producing and keep the farm workers instead of sending them home to join many who are losing jobs from different sectors.
KFC mobilized farmers to get the flowers. KAM and Elgon Kenya Ltd offered transport for the flowers through Dr. Bimal Kantaria.

The Women of Kenya Initiative was led by KEPSA Advisor, Ms. Gloria Ndekei, in distributing to Kenyatta National Hospital and Mbagathi District Hospital as a way of showing compassion both to the patients and the medical teams at the hospitals.

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