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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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ELISA T. pallidum IgG Smart Kit Test System - 00845533001168

The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
SM3Z7611G
In Commercial Distribution

  • 00845533001168 ()
SM3Z7611G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA T. pallidum IgG Test System - 00845533001151

The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
3Z7611G
In Commercial Distribution

  • 00845533001151 ()
3Z7611G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

AccuDiag ™ - 00894175000299

AccuDiag™ Taenia.solium (Cysticercosis) IgG ELISA -For the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Taenia solium in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD8105-35
In Commercial Distribution

  • 00894175000299 ()

  • 96 Tests
8105-35

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

PLATELIA - 03610520007877

PLATELIA Lyme IgG
BIO-RAD
25297
Not in Commercial Distribution

  • 03610520007877 ()
25297

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Taenia Solium IgG ELISA - 00840239035134

For the qualitative screening of serum or plasma IgG antibodies to Taenia solium using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique.NLD
DRG International Inc
EIA-3513
In Commercial Distribution

  • 00840239035134 ()
EIA-3513

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

E. Histolytica IgG ELISA - 00840239034748

The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
DRG International Inc
EIA-3474
In Commercial Distribution

  • 00840239034748 ()

  • Positive Control
  • Stop Solution
  • Chromogen TMB
  • Total Volume: 11 Milliliter
  • Total Volume: 1 Milliliter
  • Total Volume: 30 Milliliter
  • Enzyme Conjugate
  • Total Volume: 25 Milliliter
  • Negative Control
  • Wash Concentrate
  • Dilution Buffer
EIA-3474

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Entamoeba histolytica Ag (stool) ELISA - 00840239034731

This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces
DRG International Inc
EIA-3473
Not in Commercial Distribution

  • 00840239034731 ()
EIA-3473

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Entamoeba histolytica IgG ELISA - 00840239038302

The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3830
In Commercial Distribution

  • 00840239038302 ()
EIA-3830

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

VIDAS® Lyme IgG II - 03573026458270

VIDAS Lyme IgG II assay is a qualitative immunoassay intended for use on VIDAS family instrument in the presumptive detection of human IgG antibodies to Borrelia burgdorferi.
BIOMERIEUX SA
417401
In Commercial Distribution

  • 03573026458270 ()


  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips - 10816101021014

No Description
DIASORIN MOLECULAR LLC
IB0901
In Commercial Distribution

  • 10816101021014 ()
IB0901

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, reagent

Anti-Echinococcus granulosus IFA (IgG) - 04049016055655

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2320-2005 G
Not in Commercial Distribution

  • 04049016055655 ()


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

Anti-Echinococcus granulosus IFA (IgG) - 04049016055648

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2320-1010 G
Not in Commercial Distribution

  • 04049016055648 ()


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

Anti-Echinococcus granulosus IFA (IgG) - 04049016055631

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2320-1005 G
Not in Commercial Distribution

  • 04049016055631 ()


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

Anti-Echinococcus granulosus IFA (IgG) - 04049016055624

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2320-1003 G
Not in Commercial Distribution

  • 04049016055624 ()


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

RIDASCREEN® Entamoeba histolytica IgG - 04049095110023

The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Entamoeba histolytica in human serum. The test should be used for confirmation purposes when there is a suspected case of amoebiasis.
R-Biopharm AG
K1721
Not in Commercial Distribution

  • 04049095110023 ()
K1721

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Entamoeba histolytica IgG ELISA - 04048474038309

The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3830
In Commercial Distribution

  • 04048474038309 ()
EIA-3830

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Taenia Solium IgG ELISA - 04048474035131

For the qualitative screening of serum or plasma IgG antibodies to Taenia solium using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3513
In Commercial Distribution

  • 04048474035131 ()
EIA-3513

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Entamoeba histolytica IgG ELISA - 04048474034745

The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3474
In Commercial Distribution

  • 04048474034745 ()
EIA-3474

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Entamoeba histolytica Ag (stool) ELISA - 04048474034738

This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3473
Not in Commercial Distribution

  • 04048474034738 ()
EIA-3473

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

RIDASCREEN® Taenia solium IgG - 04049095110528

The RIDASCREEN® Taenia solium IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Taenia solium and its cysticerci (bladder worms) in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Taenia solium.
R-Biopharm AG
K7721
Not in Commercial Distribution

  • 04049095110528 ()
K7721

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Bordetella pertussis toxin ELISA (IgG) - 04049016085508

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 G
Not in Commercial Distribution

  • 04049016085508 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Borrelia burgdorferi US WESTERNBLOT (IgG) - 04049016126010

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2133-24001 G
In Commercial Distribution

  • 04049016126010 ()


  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Borrelia burgdorferi US WESTERNBLOT (IgG) - 04049016126003

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2133-3001 G
In Commercial Distribution

  • 04049016126003 ()


  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Bordetella pertussis (IgG) - 04049016085478

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-24001 G
In Commercial Distribution

  • 04049016085478 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Bordetella pertussis (IgG) - 04049016085447

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-1601 G
In Commercial Distribution

  • 04049016085447 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Taenia solium IgG ELISA - 07640158219706

The Taenia solium ELISA test is a qualitative enzyme immunoassay for the detection of Taenia solium antibodies in human serum samples.
Bordier affinity products S.A.
9700
In Commercial Distribution

  • 07640158219706 ()
9700

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Entamoeba histolytica IgG ELISA - 07640158219553

The Entamoeba histolytica ELISA test is a qualitative enzyme immunoassay for the detection of Entamoeba histolytica antibodies in human serum samples.
Bordier affinity products S.A.
9550
In Commercial Distribution

  • 07640158219553 ()
9550

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Acanthocheilonema viteae IgG ELISA - 07640158219409

The Acanthocheilonema viteae ELISA test is a qualitative enzyme immunoassay for the detection of Acanthocheilonema viteae antibodies in human serum samples.
Bordier affinity products S.A.
9400
In Commercial Distribution

  • 07640158219409 ()
9400

  • Wuchereria bancrofti immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

T.solium Antibody 96 Tests - 00813545026509

No Description
SCIMEDX CORPORATION
TS-96
In Commercial Distribution

  • 00813545026509 ()
TS-96

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Entamoeba histolytica IgG ELISA Test Kit - B350GSD0130130

Entamoeba histolytica IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3013
In Commercial Distribution

  • B350GSD0130130 ()
GSD01-3013

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA - B24220BPGHUE010

The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum. This assay is intended for in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
20-BPGHU-E01
In Commercial Distribution

  • B24220BPGHUE010 ()
20-BPGHU-E01

  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

JAS Diagnostics - 00817274021774

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
XL-A1C2-30
In Commercial Distribution

  • 00817274021774 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021767

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
A1C2-30
In Commercial Distribution

  • 00817274021767 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021750

HEMOGLOBIN A1C REAGENT (1x 30mL R1, 1x 9.5mL R2a, 1x 0.5mL R2b
DREW SCIENTIFIC, INC.
A1C2-30A
In Commercial Distribution

  • 00817274021750 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

NovaLisa Taenia solium IgG - ENTITAEG04200

The Taenia solium IgG ELISA is intended for the qualitative determination of IgG class antibodies against Taenia solium in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
TAEG0420
In Commercial Distribution

  • ENTITAEG04200 ()
TAEG0420

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Entamoeba histolytica IgG - ENTIENTG01400

The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ENTG0140
In Commercial Distribution

  • ENTIENTG01400 ()
ENTG0140

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EL-Anti-SARS-CoV-2 IgG - 00854473003330

ANTI-SARS-CoV-2 IgG ANTIBODY ELISA TEST KIT, 96 TESTS
THERA-TEST LABORATORIES, INC
104-130
Not in Commercial Distribution

  • 00854473003330 ()
104-130

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

Serodia TP-PA - 00850212007027

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

Serodia TP-PA - 00850212007010

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 - 05700571113011

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)

Serodia TP-PA Kits - 00869164000062

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

Serodia TP-PA Kits - 00869164000055

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

PK7400 TP HA REAGENT - 05060515140030

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

IDS SARS-COV-2 IgG - 05060169695962

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6502
In Commercial Distribution

  • 05060169695962 ()


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

ELISA HAMA IgG Test System - 00845533001335

The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.
ZEUS SCIENTIFIC, INC.
6401
In Commercial Distribution

  • 00845533001335 ()
6401

  • Human immunoglobulin G (IgG) murine conjugate antibody reagent IVD

Tissue-Tek Genie® - 00615233001979

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

Tissue-Tek Genie® - 00615233001962

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

Alinity - 00380740193867

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

Alinity - 00380740193843

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

ARCHITECT - 00380740193782

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
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