Hologic Direct Load Capture Cap Collection Kit — FLOQSwabs Informácie o produkte

Značka: Hologic

Model: Direct Load Capture Cap Collection Kit — FLOQSwabs

Typ: Informácie o produkte

The text in the box on this insert applies to US Customers only

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uvedená v rámečku se týká pouze zákazníků v USA. da Teksten i feltet på denne indlægsseddel gælder kun for kunder i USA nl De omkaderde tekst in deze bijsluiter geldt alleen

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fr Le texte encadré sur cette notice s’applique uniquement aux clients des États-Unis de Der eingerahmte Text in der Packungsbeilage betrifft nur Kunden in den USA el Το κείμενο

στο πλαίσιο σε αυτό το ένθετο ισχύει μόνο για πελάτες των Ηνωμένων Πολιτειών hu A betegtájékoztatón a keretben lévő szöveg csak az amerikai ügyfelekre vonatkozik it Il testo

nella casella in questo inserto si applica solo ai clienti statunitensi lv Šajā instrukcijā iezīmētais teksts attiecas tikai uz ASV klientiem. lt Šio intarpo langelio tekstas taikomas tik JAV

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deste folheto aplica-se apenas aos clientes dos EUA ro Textul din caseta din acest prospect este valabil exclusiv pentru clienții din SUA. sk Táto časť textu písomnej informácie pre

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este prospecto se aplica únicamente a los clientes de EE. UU. sv Texten i rutan på denna bipacksedel gäller endast för kunder i USA.

HPV005R01 Date 2022.03

Hologic, Inc.

Direct Load Capture Cap Collection Kit - FLOQSwabs®

• Rx Only

• For in vitro diagnostic use

• This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories

• For use under an Emergency Use Authorization (EUA) Only

• When used with the Aptima SARS-CoV-2 assay, this product has been authorized for the collection and maintenance of mid-turbinate nasal and nasopharyngeal swab specimens

as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens

• When used with the Aptima SARS-CoV-2/Flu assay, this product has been authorized for the collection and maintenance of nasopharyngeal swab specimens as an aid in

detection of nucleic acid from SARS-CoV-2, Flu A, and/or Flu B, not for any other viruses or pathogens

• The emergency use of this product 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)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated,

or authorization is revoked sooner

• The Direct Load Capture Cap Collection Kit - FLOQSwabs® is for use with the Aptima SARS-CoV-2 assay and Aptima SARS-CoV-2/Flu assay only.

The collection kit instructions for use describe how to perform specimen collection. The current electronic instructions for use for the Direct Load Capture Cap Collection Kit-

FLOQSwabs® are available at https://www.hologic.com/package-inserts

• To request a paper copy of the instructions for use of the Direct Load Capture Cap Collection Kit - FLOQSwabs®, free of charge, please contact Hologic Technical Support

at [email protected]

• This product information card does not contain the full instructions for use