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The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
NO14S, NO15S, NO05S
In Commercial Distribution
- 00860002028095 ()
- Oral/upper respiratory tract specimen collection kit IVD, home-use
Case of 5 for Mojo First Responder-Intermediate
Your Mojo Medical Bag is equipped
with MARCH Medical Gear featuring
simple treatment icons and
color-coding below:
MASSIVE HEMORRAHAGE
AIRWAY
RESPIRATION
CIRCULATION
HEAD & HYPOTHERMIA
Safeguard US Operating, LLC
01
In Commercial Distribution
- M6898330305010 ()
83-303-05
- First aid kit, medicated
The Emergency Preparedness Mobile Kit - Mobile Aid Kit Advanced is designed for those who have completed a Basic Life Support (BLS) course and/or are certified to diagnose and treat patients.
Altitude Technologies Inc.
01377HC
In Commercial Distribution
- 00850018201575 ()
01377HC
- First aid kit, medicated
The Emergency Preparedness Mobile Kit - Mobile Aid Kit Advanced is designed for those who have completed a Basic Life Support (BLS) course and/or are certified to diagnose and treat patients.
Altitude Technologies Inc.
01377RD
In Commercial Distribution
- 00850018201568 ()
01377RD
- First aid kit, medicated
The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
LUMIQUICK DIAGNOSTICS, INC.
1N40C5-1-US-BS
In Commercial Distribution
- 00855636003723 ()
- 00855636003716 ()
- 00855636003730 ()
- 00855636003747 ()
- 00855636003754 ()
- 00855636003761 ()
- 00855636003778 ()
- 00855636003785 ()
1N40C5-1-US-BS
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
The Access SARS-CoV-2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate). The Access SARS-CoV-2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgM should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
The Access SARS-CoV-2 IgM assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58957
In Commercial Distribution
- 15099590738617 ()
C58957
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Set provides medical support for bleeding control and wound care to facilitate injuries that may happen in or around pools, or areas of high humidity or moisture until further advanced care arrives.
Safeguard US Operating, LLC
07
In Commercial Distribution
- M68924100070 ()
24-100
- First aid kit, medicated
The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard.
NanoEnTek, Inc.
FIC-COALQ
In Commercial Distribution
- 08809317540917 ()
FIC-COALQ
- SARS-CoV-2 total antibody IVD, control
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals who are suspected of COVID-19 by their healthcare provider.
Alere Scarborough, Inc.
195-000
In Commercial Distribution
- 10811877011290 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG II assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG II should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
The Access SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69057
In Commercial Distribution
- 15099590742744 ()
C69057
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay