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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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ARCHITECT - 00380740193768

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

ARCHITECT - 00380740192150

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

Alinity - 00380740192136

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

Alinity - 00380740192129

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

ARCHITECT - 00380740191832

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

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 00404847451894

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)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 00404847451887

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)

Echinococcus IgG ELISA - 00404847434729

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)

Vista COV2G Assay - 00630414607139

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 CV2GAssay - 00630414607030

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

IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG - 00630414964164

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

IMMULITE® 2000 Systems HPG H.pylori IgG - 00630414961644

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

IMMULITE® 2000 Systems HPG H.pylori IgG - 00630414961637

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

Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041

No Description
FUJIREBIO INC.
235041
In Commercial Distribution

  • 04987270235041 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
  • Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Beckman Coulter PK TP System - 04987270226964

No Description
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

AccuDiag ™ - 00894175000138

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 - 10758750033362

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

VITROS - 10758750033355

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199919
In Commercial Distribution

  • 10758750033355 ()
6199919

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

VITROS - 10758750034420

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 - 10758750034413

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 - 10758750033607

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

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 00840239051899

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 International Inc
EIA-5189
In Commercial Distribution

  • 00840239051899 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 00840239051882

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 International Inc
EIA-5188
In Commercial Distribution

  • 00840239051882 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Echinococcus IgG ELISA - 00840239034724

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).
DRG International Inc
EIA-3472
In Commercial Distribution

  • 00840239034724 ()
EIA-3472

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS Q FEVER PHASE II IgG - 08033891322083

No Description
DIESSE DIAGNOSTICA SENESE SPA
81171
In Commercial Distribution

  • 08033891322083 ()
81171

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-SARS-CoV-2 S1 Curve ELISA (IgG) - 04049016150244

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601-20 G
Not in Commercial Distribution

  • 04049016150244 ()


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

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 04048474051896

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
In Commercial Distribution

  • 04048474051896 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 04048474051889

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
In Commercial Distribution

  • 04048474051889 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Echinococcus IgG ELISA - 04048474034721

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).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3472
In Commercial Distribution

  • 04048474034721 ()
EIA-3472

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-SARS-CoV-2 ELISA (IgG) - 04049016145554

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601 G
In Commercial Distribution

  • 04049016145554 ()


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

LIAISON® SARS-CoV-2 S1/S2 IgG - 08056771103664

No Description
DIASORIN SPA
311460
In Commercial Distribution

  • 08056771103664 ()


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

LIAISON® H. pylori IgG - 08056771602044

No Description
Diasorin Inc.
318980
In Commercial Distribution

  • 08056771602044 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Echinococcus multilocularis (Em18) IgG ELISA - 07640158219317

The Echinococcus multilocularis (Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples. This test is intended for post-operative and/or post-therapeutic follow-up of infected patients.
Bordier affinity products S.A.
9310
In Commercial Distribution

  • 07640158219317 ()
9310

  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Echinococcus multilocularis (Em2-Em18) IgG ELISA - 07640158219300

The Echinococcus multilocularis (Em2-Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples.
Bordier affinity products S.A.
9300
In Commercial Distribution

  • 07640158219300 ()
9300

  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-SARS-CoV-2 - 07613336179451

No Description
Roche Diagnostics GmbH
09203095190
In Commercial Distribution

  • 07613336179451 ()
09203095190

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

Elecsys Anti-SARS-CoV 2 - 07613336179444

No Description
Roche Diagnostics GmbH
09203079190
In Commercial Distribution

  • 07613336179444 ()
09203079190

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

SCoV-2 Detect™ IgG ELISA - B379COVEG1

No Description
INBIOS INTERNATIONAL, INC
COVE-G
In Commercial Distribution

  • B379COVEG1 ()


  • SARS-CoV-2 immunoglobulin G (IgG) 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)

Echinococcus Granulosus IgG ELISA - B24220EGGHUE010

The Echinococcus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Echinococcus in human serum and plasma. This assay is intended for in vitro diagnostic use only.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
20-EGGHU-E01
In Commercial Distribution

  • B24220EGGHUE010 ()
20-EGGHU-E01

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells - 00816870024875

No Description
MONOBIND, INC.
12525-300
In Commercial Distribution

  • 00816870024875 ()

  • Width: 7.75 Inch
12525-300B

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

SARS-CoV-2 IgG AccuBind ELISA Test System - 192 Wells - 00816870023601

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

  • 00816870023601 ()

  • Width: 7.75 Inch
11925-300B

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

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)

SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 Wells - 00816870024868

No Description
MONOBIND, INC.
12525-300
In Commercial Distribution

  • 00816870024868 ()

  • Width: 7.75 Inch
12525-300A

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

Diamedix - 00817273020358

"720-640 EBV-EA-D IgG Test Kit"
DIAMEDIX CORPORATION
720-640
In Commercial Distribution

  • 00817273020358 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diamedix - 00817273020273

"720-460 anti-TG IgG Test Kit"
DIAMEDIX CORPORATION
720-460
In Commercial Distribution

  • 00817273020273 ()


  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diamedix - 00817273020266

"720-450 anti-TPO IgG Test Kit"
DIAMEDIX CORPORATION
720-450
In Commercial Distribution

  • 00817273020266 ()


  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diamedix - 00817273020259

"720-440 anti-PR-3 (C-ANCA) IgG Test Kit"
DIAMEDIX CORPORATION
720-440
In Commercial Distribution

  • 00817273020259 ()


  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diamedix - 00817273020242

"720-430 anti-MPO (P-ANCA) IgG Test Kit"
DIAMEDIX CORPORATION
720-430
In Commercial Distribution

  • 00817273020242 ()


  • Echinococcus multilocularis 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
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