SEARCH RESULTS FOR: (*Imitation Laguna College of Art*)(9245 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OSOM COVID-19 Antigen Control Kit
SEKISUI DIAGNOSTICS, LLC
1068
In Commercial Distribution

  • 00742860000034 ()
  • 10742860000031 ()
1068

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
OSOM COVID-19 Antigen Rapid Test
SEKISUI DIAGNOSTICS, LLC
1066-40
In Commercial Distribution

  • 00742860000027 ()
  • 10742860000024 ()
1066-40

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
Genabio Diagnostics Inc.
N/A
In Commercial Distribution

  • 00810143620184 ()
  • 81014362018400 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
ADVIN BIOTECH, INC.
ABCass(5)-CAN-AO
In Commercial Distribution

  • B115ABCASS5CANAO1 ()
  • B115ABCASS5CANAO0 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
ADVIN BIOTECH, INC.
ABCass(2)-CAN-AO
In Commercial Distribution

  • B115ABCASS2CANAO1 ()
  • B115ABCASS2CANAO0 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
Neumodx Molecular, Inc.
300800
In Commercial Distribution

  • 00814278021267 ()
  • 10814278021264 ()
300800

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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
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 Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution

  • 15099590738655 ()
C58963

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgM calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58958
In Commercial Distribution

  • 15099590738624 ()
C58958

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator
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