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ELISA EBNA-1 IgG Smart Kit Test Sytem - 00845533000451

The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9461G
In Commercial Distribution

  • 00845533000451 ()
SM9Z9461G

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

ELISA EBNA-1 IgG Q Test Sytem - 00845533000444

The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9461GB
In Commercial Distribution

  • 00845533000444 ()
Q9Z9461GB

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

ELISA EBNA-1 IgG Test Sytem - 00845533000437

The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9461G
In Commercial Distribution

  • 00845533000437 ()
9Z9461G

  • 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

IMMCO DIAGNOSTICS - 00845714003066

IgA/IgG FITC Conjugate w/EB
IMMCO DIAGNOSTICS, INC.
2113-15
In Commercial Distribution

  • 00845714003066 ()

  • 15 ml
2113-15

  • Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD

IMMCO DIAGNOSTICS - 00845714003059

IgA/IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2113X
In Commercial Distribution

  • 00845714003059 ()

  • 5 ml
2113X

  • Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD

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)

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)

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

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

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)

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)

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

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

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

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)

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

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

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

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

CLIAWAIVED INC - 00183278000436

CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)
Cliawaived, Inc.
CLIA-INGM-MC42
In Commercial Distribution

  • 00183278000436 ()
CLIA-INGM-MC42

  • 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

PRIMO - 00840216117655

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

  • 00840216117655 ()


  • Freestanding patient positioner, reusable

PRIMO - 00840216117648

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

  • 00840216117648 ()


  • Freestanding patient positioner, reusable

Millennium - 00190776183882

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

  • 00190776183882 ()


  • Surgical mallet

Trinity Biotech - 05391516748742

EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020M
In Commercial Distribution

  • 05391516748742 ()
44-2020M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748735

EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020GV
In Commercial Distribution

  • 05391516748735 ()
44-2020GV

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516746199

Lyme Disease IgM IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100M
In Commercial Distribution

  • 05391516746199 ()
32-5100M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516746182

Lyme Disease IgG IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100G
In Commercial Distribution

  • 05391516746182 ()
32-5100G

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Rickettsia IgG ELISA - 00840239052971

The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of human IgG class antibody to Spotted Fever Group Rickettsia, to be used as an aid in the diagnosis of human infection by these pathogens.
DRG International Inc
EIA-5297
In Commercial Distribution

  • 00840239052971 ()
EIA-5297

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

IFA: Legionella Mosaic 4 (IgG) - 04049016089537

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-2005-4 G
Not in Commercial Distribution

  • 04049016089537 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA: Legionella Mosaic 4 (IgG) - 04049016089520

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1010-4 G
Not in Commercial Distribution

  • 04049016089520 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA: Legionella Mosaic 4 (IgG) - 04049016089513

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1005-4 G
Not in Commercial Distribution

  • 04049016089513 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

West Nile Virus DxSelect™ Negative Control - 10816101022042

No Description
DIASORIN MOLECULAR LLC
EL0312
In Commercial Distribution

  • 10816101022042 ()
EL0312

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