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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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FUJIREBIO INC.
226964
In Commercial Distribution

  • 04987270226964 ()

  • Size Type = Tests Per Kit; Size Unit = 3000; Unit of Measure = Tests
PH3000

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.
NEWMARKET BIOMEDICAL LIMITED
B11186
In Commercial Distribution

  • 05060515140030 ()

  • 3600 tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
220 test kit
FUJIREBIO DIAGNOSTICS, INC.
1633
In Commercial Distribution

  • 00850212007027 ()

  • Size Type = Tests per Kit; Size Unit = 220; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
100 test kit
FUJIREBIO DIAGNOSTICS, INC.
1626
In Commercial Distribution

  • 00850212007010 ()

  • Size Type = Tests per Kit; Size Unit = 100; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
SARS-CoV-2 IgG ELISA Kit
AGILENT TECHNOLOGIES, INC.
K1919
In Commercial Distribution

  • 05700571113011 ()

  • 180 tests


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
anti-IgG Rabbit Monoclonal Antibody [RM116], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8383-M250
In Commercial Distribution

  • 00615233001962 ()
8383-M250

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD
anti-IgG Rabbit Monoclonal Antibody [RM116], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8383-C010
In Commercial Distribution

  • 00615233001979 ()
8383-C010

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD
Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381272
In Commercial Distribution

  • 00630414964164 ()
LKHPG1

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381335
In Commercial Distribution

  • 00630414961644 ()
L2KHPG6

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381336
In Commercial Distribution

  • 00630414961637 ()
L2KHPG2

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Vista COV2G Assay
Siemens Healthcare Diagnostics Inc.
11417771
Not in Commercial Distribution

  • 00630414298382 ()
  • 00630414607139 ()
K7771

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Dimension CV2G Assay
Siemens Healthcare Diagnostics Inc.
11417770
Not in Commercial Distribution

  • 00630414298375 ()
  • 00630414607030 ()
RF870

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
220 test kits
FUJIREBIO DIAGNOSTICS, INC.
234976
In Commercial Distribution

  • 00869164000062 ()

  • 220 tests per kit


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
100 test kit
FUJIREBIO DIAGNOSTICS, INC.
234952
In Commercial Distribution

  • 00869164000055 ()

  • 100 tests per kit


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test
Abbott Ireland Diagnostics
06S6130
In Commercial Distribution

  • 00380740193867 ()
06S6130

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test
Abbott Ireland Diagnostics
06S6120
In Commercial Distribution

  • 00380740193843 ()
06S6120

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test
Abbott Ireland Diagnostics
06S6030
In Commercial Distribution

  • 00380740193782 ()
06S6030

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test
Abbott Ireland Diagnostics
06S6020
In Commercial Distribution

  • 00380740193768 ()
06S6020

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
SARS-CoV-2 IgG Reagent Kit 500 Tests
ABBOTT LABORATORIES
06R8630
In Commercial Distribution

  • 00380740192150 ()
06R8630

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
SARS-CoV-2 IgG Reagent Kit 1000 Tests
ABBOTT LABORATORIES
06R9030
In Commercial Distribution

  • 00380740192136 ()
06R9030

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
SARS-CoV-2 IgG Reagent Kit 200 Tests
ABBOTT LABORATORIES
06R9020
In Commercial Distribution

  • 00380740192129 ()
06R9020

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
SARS-CoV-2 IgG Reagent Kit 100 Tests
ABBOTT LABORATORIES
06R8620
In Commercial Distribution

  • 00380740191832 ()
06R8620

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5189
Not in Commercial Distribution

  • 00404847451894 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5188
Not in Commercial Distribution

  • 00404847451887 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Echinococcus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Echinococcus in human serum and plasma (EDTA-, heparin- or citrate plasma). This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3472
Not in Commercial Distribution

  • 00404847434729 ()
EIA-3472

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag™ Echinococcus IgG ELISA
Diagnostic Automation, Inc.
DACD8202-35
In Commercial Distribution

  • 00894175000138 ()

  • 96 Tests
8202-35

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199960
In Commercial Distribution

  • 10758750034413 ()
6199960

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199951
In Commercial Distribution

  • 20758750033604 ()
  • 10758750033607 ()
6199951

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199920
In Commercial Distribution

  • 10758750033362 ()
6199920

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