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The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, influenza A and influenza B proteins using self-collected anterior nares nasal swab samples from individuals aged 14 years or older. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset.
LUMIQUICK DIAGNOSTICS, INC.
71118-1T
In Commercial Distribution
- 00855636003808 ()
- 00855636003815 ()
- 00855636003822 ()
- 00855636003839 ()
- 00855636003846 ()
- 00855636003853 ()
71118-1T
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two Xenon Xe 129 Gas Blend cylinders, one NF-grade UHP nitrogen cylinder and one industrial nitrogen cylinder to be connected to the HPX Hyperpolarizer.
Polarean, Inc.
Rev E
In Commercial Distribution
- 00850045949037 ()
45660
- Lung MRI xenon hyperpolarization system
Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories.
Genbody Inc.
COVAG025-U
In Commercial Distribution
- 08800076700437 ()
- 08800076700475 ()
COVAG025-U
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
IMPLANT SOLUTIONS PTY LTD
1
In Commercial Distribution
- D102BAR0 ()
- Dental implant suprastructure, permanent, custom-made
- Dental implant suprastructure, temporary, custom-made
The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only.
The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution
- 15099590742768 ()
C69059
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
The Emergency Preparedness Medical Kit -Expedition (EPMK) – Expedition Kit is intended for larger groups and contains all the necessary supplies to treat a wide variety of injuries associated with backcountry emergencies such as severe bleeding, bone fractures, extended would management, blister care, dental care, and hypothermia management.
Altitude Technologies Inc.
01390RD
In Commercial Distribution
- 00850018201513 ()
01390RD
- First aid kit, medicated
The Emergency Preparedness Medical Kit -Expedition (EPMK) – Expedition Kit is intended for larger groups and contains all the necessary supplies to treat a wide variety of injuries associated with backcountry emergencies such as severe bleeding, bone fractures, extended would management, blister care, dental care, and hypothermia management.
Altitude Technologies Inc.
01390HC
In Commercial Distribution
- 00850018201506 ()
01390HC
- First aid kit, medicated
Upgrade to the Adventurer + Bleeding & CPR Basic Kit with high-quality emergency items such as the SWAT-Tourniquet and a CPR face shield to address major life-threatening bleeding and cardiac arrest. The Bleeding & CPR Basic Kit comes inside the Minimalist Bag and is designed to attach to the inside of the Adventurer Kit.
Altitude Technologies Inc.
01424BC
In Commercial Distribution
- 00850018201414 ()
01424BC
- First aid kit, medicated
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-20T
In Commercial Distribution
- 00855402007979 ()
R0182CHT
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-5T
In Commercial Distribution
- 00855402007962 ()
R0182CHT
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing