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(US Only) Accula™ SARS-CoV-2 Test

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(US Only) Accula™ SARS-CoV-2 Test

United States only. CLIA number required. FDA-EUA Approved.
*Price in USD($)
*Current Procedural Terminology (CPT) code: 87635

Instructions for Use (pdf)
FDA-EUA Authorization Letter (pdf)

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Description

** CLIA number Required. All Rapid Tests are FINAL SALE – we cannot offer cancellations or refunds after your order has shipped. **

Each Box Contains:

  • Collection Swabs: 25 sterile nasal swabs
  • SARS-CoV-2 Buffer: 25 single-use vials of solution containing 5 mL of buffer
  • Transfer Pipette: 25 single-use, fixed volume pipettes
  • Accula SARS-CoV-2 Test Cassette: 25 Single-use, foil-pouched with desiccant and Test Cassette
  • SARS-CoV-2 High Positive Control Swab: DNA Based Synthetic Oligo dried onto a swab well-above the limit of detection
  • SARS-CoV-2 Low Positive Control Swab: DNA Based Synthetic Oligo dried onto a swab near the limit of detection
  • SARS-CoV-2 Negative Control Swab: Buffer solution dried onto a swab
  • Documentation: 1 Self-collection Quick Reference and 1 Electronic Instructions for Use (EIFU) card

Specification:

  • Test type: Molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA.
  • Specimen type: Nasal
  • Turnaround time: Approximately 30 minutes

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