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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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SeraQuest - 00850487007364

Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB NA G
In Commercial Distribution

  • 00850487007364 ()
Q01-460

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007166

Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB NA G
In Commercial Distribution

  • 00850487007166 ()
Q01-460

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Kallestad - 00847865001496

MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

IMMUNO CONCEPTS - M7490081311

Custom - EBNA FA BP - 3900 wells
IMMUNO CONCEPTS INC
8131
In Commercial Distribution

  • M7490081311 ()
8131

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

LIAISON® EBNA IgG - 08056771101752

No Description
DIASORIN SPA
310520
In Commercial Distribution

  • 08056771101752 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

EBV-EA IgG ELISA - 00840239027962

The DRG Epstein Barr Virus Early Antigen (EBV-EA) IgG ELISA test system provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM.
DRG International Inc
EIA-2796
Not in Commercial Distribution

  • 00840239027962 ()
EIA-2796

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Epstein Barr Virus VCA IgG ELISA - 00840239027931

The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgG test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus
DRG International Inc
EIA-2793
Not in Commercial Distribution

  • 00840239027931 ()
EIA-2793

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Epstein Barr Virus VCA IgG ELISA - 04048474027938

The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgG test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus,
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2793
Not in Commercial Distribution

  • 04048474027938 ()
EIA-2793

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

EBV-EA IgG ELISA - 04048474027969

The DRG Epstein Barr Virus Early Antigen (EBV-EA) IgG ELISA test system provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2796
Not in Commercial Distribution

  • 04048474027969 ()
EIA-2796

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Rickettsia typhi IgG ELISA Kit - B266RTG96K0

An ELISA format for measuring IgG antibody against typhus group Rickettsia
FULLER LABORATORIES
N/A
In Commercial Distribution

  • B266RTG96K0 ()
RTG-96K

  • Multiple Rickettsia species (typhus group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ASI EBNA IgG EIA Test - 00816057020638

Detection of Epstein Barr Nuclear Antigen
ARLINGTON SCIENTIFIC, INC.
NC-870096-AG
In Commercial Distribution

  • 00816057020638 ()

  • 96 Test
NC-870096-AG

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Fungal Serology - 10634853000213

Candida Antiserum, 2mL
MICROBIOLOGICS INC.
200185
Not in Commercial Distribution

  • 10634853000213 ()
200185

  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

MTS - 10758750005987

MTS Anti-IgG,-C3d Card
MICRO TYPING SYSTEMS, INC
MTS084014
In Commercial Distribution

  • 10758750005987 ()
MTS084014

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

BIOCLONE - 10758750003624

Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML Green
ORTHO-CLINICAL DIAGNOSTICS, INC.
716980
In Commercial Distribution

  • 10758750003624 ()
716980

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

BIOCLONE - 10758750003600

Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green
ORTHO-CLINICAL DIAGNOSTICS, INC.
716910
In Commercial Distribution

  • 10758750003600 ()
716910

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

BIOCLONE - 10758750003471

Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716080
In Commercial Distribution

  • 10758750003471 ()
716080

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

BIOCLONE - 10758750003457

Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716000
In Commercial Distribution

  • 10758750003457 ()
716000

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

DG Gel 8 Direct Coombs - 08437014205909

The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test of two different human blood samples. It allows to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions. For use with the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210129
In Commercial Distribution

  • 08437014205909 ()


  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

Mumps Negative Control - B110MUN80100

No Description
Bion Enterprises, Ltd.
MUN-8010
In Commercial Distribution

  • B110MUN80100 ()
MUN-8010

  • Mumps virus immunoglobulin M (IgM) antibody IVD, control
  • Mumps virus immunoglobulin G (IgG) antibody IVD, control

Measles Negative Control - B110MEN60100

No Description
Bion Enterprises, Ltd.
MEN-6010
In Commercial Distribution

  • B110MEN60100 ()
MEN-6010

  • Measles virus immunoglobulin G (IgG) antibody IVD, control
  • Measles virus immunoglobulin M (IgM) antibody IVD, control

Echovirus Screen Virus Antigen Substrate, 12 wells, For IFA Test System - B110EC44120

No Description
Bion Enterprises, Ltd.
EC-4412
In Commercial Distribution

  • B110EC44120 ()
EC-4412

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, reagent

CMV Negative Control - B110CMN20100

No Description
Bion Enterprises, Ltd.
CMN-2010
In Commercial Distribution

  • B110CMN20100 ()
CMN-2010

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Diamedix - 00817273020181

"720-350 HSV 1&2 IgM Test Kit"
DIAMEDIX CORPORATION
720-350
In Commercial Distribution

  • 00817273020181 ()


  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Diamedix - 00817273020167

"720-330 CMV IgM Test Kit"
DIAMEDIX CORPORATION
720-330
In Commercial Distribution

  • 00817273020167 ()


  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

LT Blood Cross Matching Card - 06974621793150

No Description
Zhuhai Longtime Biological Technology Co., Ltd
BCM-8
In Commercial Distribution

  • 06974621793150 ()
  • 16974621793157 ()


  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

LT Blood Cross Matching Card - 06974621793143

No Description
Zhuhai Longtime Biological Technology Co., Ltd
BCM-6
In Commercial Distribution

  • 06974621793143 ()
  • 16974621793140 ()


  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

PRIMO - 00840216117648

G&G ANGLED WEDGE BUNDLE STANDARD
Asp Global, LLC
GGTS08
In Commercial Distribution

  • 00840216117648 ()


  • Freestanding patient positioner, reusable

PRIMO - 00840216117655

G&G ANGLED WEDGE BUNDLE BARIATRIC
Asp Global, LLC
GGTS08B
In Commercial Distribution

  • 00840216117655 ()


  • Freestanding patient positioner, reusable

Millennium - 00190776183882

Mallet, , dia. , stainless steel, g, g
Avalign Technologies, Inc.
1-FL036R
In Commercial Distribution

  • 00190776183882 ()


  • Surgical mallet

CLIAWAIVED INC - 00183278000443

CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Only" (Single kit includes 1 device, 1 lancets, 1 dropper, 1 single use buffer, 1 alcohol wipe, 1 procedure card and insert)
Cliawaived, Inc.
CLIA-INGM-MC42S
In Commercial Distribution

  • 00183278000443 ()
CLIA-INGM-MC42S

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
  • SARS-CoV-1 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
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