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A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.
Hans Hepp GmbH & Co. KG
89114
In Commercial Distribution
- 04007418891141 ()
- Public face mask, single-use
An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
TF-8150
In Commercial Distribution
- 10895160002790 ()
- 00895160002793 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It consists of a laser optical pumping system and a cryogenic xenon condenser system.
With the use of the HPX Gas Handling Manifold, the Xenon Xe 129 Gas Blend is delivered to the HPX Hyperpolarizer where it undergoes spin exchange optical pumping (SEOP) process, which produces XENOVIEW™.
Polarean, Inc.
Rev E
In Commercial Distribution
- 00850045949006 ()
49820
- Lung MRI xenon hyperpolarization system
First Aid Kit, with 16 Units in a metal case. Contains first aid supplies to help with treatment of minor injuries.
Acme United Corporation
5201
In Commercial Distribution
- 00738743052016 ()
5201
- First aid kit, medicated
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
A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution
- 10895160002660 ()
- 00895160002663 ()
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
The 6PAK includes all of our personal aid kits: GermPAK, WoundPAK, BurnPAK, MedsPAK, ToolPAK, and BleederPAK, plus an Emergency First Aid Pocket Guide.
Altitude Technologies Inc.
01403
In Commercial Distribution
- 00850018201421 ()
01403
- First aid kit, medicated
The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only.
The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58964
In Commercial Distribution
- 15099590738662 ()
C58964
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
The Access SARS-CoV-2 IgM QC is intended for monitoring system performance of the Access SARS-CoV-2 IgM assay. The Access SARS-CoV-2 IgM QC is for use on the Access Family of Immunoassay Systems only.
The Access SARS-CoV-2 IgM QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58959
In Commercial Distribution
- 15099590738631 ()
C58959
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, control
PRO1TEK 2+ Patient Specialty IFAK Kit - Contains Bleeding Control tools with the addition of a Hemostatic Dressing and other Trauma Kit and First-Aid Equipment.
Pro1tek
B283PTOXFIFAK010
In Commercial Distribution
- B283PTOXFIFAK010 ()
- First aid kit, medicated