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EUA Documentation

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Premier Biotech

• PBT-Instructions For Use (PI)
  
• Fact Sheet – Healthcare Providers
  
• Fact Sheet – Recipients
  
• EUA Letter

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RightSign

• RS-Instructions For Use (PI)
  
• Fact Sheet – Healthcare Providers
  
• Fact Sheet – Recipients
  
• EUA Letter

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FaStep

• FS-Instructions For Use (PI)
  
• Procedure Guide
• EUA Letter

[/et_pb_text][/et_pb_column][/et_pb_row][/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” admin_label=”section” _builder_version=”4.16″ background_color=”#e46a15″ parallax=”on” parallax_method=”off” custom_padding=”2%||2%||true|false” custom_padding_tablet=”30px|0|30px|0|true” custom_padding_phone=”20px||20px||true” transparent_background=”off” global_colors_info=”{}”][et_pb_row admin_label=”row” _builder_version=”4.16″ global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_text_color=”#ffffff” locked=”off” global_colors_info=”{}”]Statements And Conditions:

• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has not been FDA cleared or approved;
• This test has been authorized only for the presence of lgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
• This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only)
• Not for screening of donated blood

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