Abbott RealTime SARS-CoV-2 Application CD-ROM

Abbott Universal Collection Kit

Abbott RealTime SARS-CoV-2 Control Kit

Abbott RealTime SARS-CoV-2 Amplification Reagent Kit

Alinity m SARS-CoV-2 Application Specification File

Alinity m SARS COV-2 Application Specification File

Alinity m SARS-CoV-2 Application Specification

Alinity m SARS-CoV-2 Application Specification File

Alinity m SARS-CoV-2 CTRL Kit

Alinity m SARS-CoV-2 AMP Kit

Alinity m Resp-4-Plex Application Specification File

Alinity m Resp-4-Plex Application Specification File

Alinity m Resp-4-Plex Application Specification File

Alinity m Resp-4-Plex CTRL Kit

Alinity m Resp-4-Plex AMP Kit

Abbott Bulk Universal Collection Kit

IVD reagent kit containing 30 tests.

IVD reagent kit containing 30 tests.

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. Black color

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells.

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color

App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test

Void Filling Caps for sealing Biomeme PCR Go-Strips during thermocycling. Caps only.

RNA Extraction Kit containing cartridges, syringes, and binding column tips.

Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit and Void Filling Caps.

Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit.

Tubes filled with 3mL aliquots of Biomemes DNA/RNA Preservation buffer for sample collection, storage, and preservation at room temperature. Pack of 100 pre-filled tubes.

RNA Process Control for Biomeme's SARS-CoV-2 assay form factors (Go-Strips, Go-Plate, or Bulk Vials)

Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.

Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Assay only.

Lyra SARS-CoV-2 Assay

SARS-CoV-2 Direct Assay

Solana SARS-CoV-2 Assay

Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).

Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).

Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).

EUA

The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a 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. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.

The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of anelectro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary toorchestrate in-vitro diagnostic tests within the inserted Test Cassette.

The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware