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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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SARS-CoV-2 IgG AccuBind ELISA Test System - 96 Wells - 00816870023595

No Description
MONOBIND, INC.
11925-300
In Commercial Distribution

  • 00816870023595 ()

  • Width: 7.75 Inch
11925-300A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Access SARS-CoV-2 IgG II - 15099590742744

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

Access SARS-CoV-2 IgG - 15099590738648

The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG 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. 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 assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58961
In Commercial Distribution

  • 15099590738648 ()
C58961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

FREND COVID-19 total Ab - 08809317540924

The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.
NanoEnTek, Inc.
FREND COVID-19 total Ab
In Commercial Distribution

  • 08809317540924 ()
FRCOA 020

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Nano-CheckTM Dengue IgM/IgG - 00895160002489

An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8144
In Commercial Distribution

  • 00895160002489 ()
  • 10895160002486 ()
MD8144

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical

SCoV-2 Detect™ IgG Rapid Test - B379COVGRE1

No Description
INBIOS INTERNATIONAL, INC
COVG-RE
In Commercial Distribution

  • B379COVGRE1 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

ACON SARS-CoV-2 IgG/IgM Rapid Test - 00682607200979

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Nano-CheckTM COVID-19 IgG/IgM Antibody Test - 00895160002663

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

Rapid Response - 10722066005115

COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

QuickProfile™ 2019-nCoV IgG/IgM Antibody Test - M90171108B0

QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
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