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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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First Aid Only - 00092265910941

First Aid Kit in a Plastic Cabinet with SmartCompliance boxes. Kit designed for food service industry, contains first aid supplies to help treat minor injuries.
Acme United Corporation
91094
In Commercial Distribution

  • 00092265910941 ()
91094

  • First aid kit, medicated

Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit - B350GSD0110290

Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1029
Not in Commercial Distribution

  • B350GSD0110290 ()
GSD01-1029

  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit - B350GSD0110280

Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1028
Not in Commercial Distribution

  • B350GSD0110280 ()
GSD01-1028

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

Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit - B350GSD0110300

Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1030
Not in Commercial Distribution

  • B350GSD0110300 ()
GSD01-1030

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

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

Access SARS-CoV-2 IgG II Calibrator - 15099590742751

The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69058
In Commercial Distribution

  • 15099590742751 ()
C69058

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Poolside Medical Rescue Set - M68924100070

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

Access SARS-CoV-2 IgG Calibrator - 15099590738655

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

Access SARS-CoV-2 IgM Calibrator - 15099590738624

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

Mojo First Responder Bag - Intermediate - M68983303040

Mojo Medical Bags are equipped with MARCH Medical Gear in our simplified, color-coded treatment system linking icon identifiers to a treatment category within the MARCH protocol. MASSIVE HEMORRHAGE AIRWAY RESPIRATION CIRCULATION HEAD & HYPOTHERMIA
Safeguard US Operating, LLC
04
In Commercial Distribution

  • M68983303040 ()
83-303

  • First aid kit, medicated
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