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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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B. burgdorferi IgG/IgM ELISA - 04048474028096

The Borrelia burgdorferi IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2809
In Commercial Distribution

  • 04048474028096 ()
EIA-2809

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

Borrelia burgdorferi IgG (Lyme) ELISA - 04048474028102

The Borrelia burgdorferi IgG ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2810
In Commercial Distribution

  • 04048474028102 ()
EIA-2810

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

Echinococcus granulosus IgG ELISA - 07640158219355

The Echinococcus granulosus ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus granulosus (and Echinococcus multilocularis) antibodies in human serum samples.
Bordier affinity products S.A.
9350
In Commercial Distribution

  • 07640158219355 ()
9350

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EBV-VCA IgG Test System, 120 Tests - B110EBG1200

No Description
Bion Enterprises, Ltd.
EBG-120
In Commercial Distribution

  • B110EBG1200 ()
EBG-120

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

ASI EB VCA IgG EIA Test - 00816057020645

Detection of Epstein Barr Viral Capsid Antigen
ARLINGTON SCIENTIFIC, INC.
NC-880096-AG
In Commercial Distribution

  • 00816057020645 ()

  • 96 Test
NC-880096-AG

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

EBV VCA IgG 10 wl; 10 pk - 00813545025564

No Description
SCIMEDX CORPORATION
I-EBV01X
In Commercial Distribution

  • 00813545025564 ()
I-EBV01X

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

EBV-VCA IgG 120 Test Kit - 00813545025540

No Description
SCIMEDX CORPORATION
I-EBV01G
In Commercial Distribution

  • 00813545025540 ()
I-EBV01G

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

Filaria Antibody 96 Tests - 00813545025427

No Description
SCIMEDX CORPORATION
FI-96
In Commercial Distribution

  • 00813545025427 ()
FI-96

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

Echinococcus Antibody 96 Tests - 00813545025380

No Description
SCIMEDX CORPORATION
EG-96
In Commercial Distribution

  • 00813545025380 ()
EG-96

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Echinococcus IgG ELISA Test Kit - B350GSD0130030

Echinococcus IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3003
In Commercial Distribution

  • B350GSD0130030 ()
GSD01-3003

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit - B3507206400

Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit
Gold Standard Diagnostics Corporation
720-640
In Commercial Distribution

  • B3507206400 ()
720-640

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

Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit - B3507206200

Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
720-620
In Commercial Distribution

  • B3507206200 ()
720-620

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

Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit - B3507206000

Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit
Gold Standard Diagnostics Corporation
720-600
In Commercial Distribution

  • B3507206000 ()
720-600

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

BIOBASE - 06971674867906

No Description
Biobase Biodustry(Shandong)Co., Ltd.
Calibrator: 1mL×1
In Commercial Distribution

  • 06971674867906 ()


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

BIOBASE - 06971674867661

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:50mL×2 R2:10mL×2
In Commercial Distribution

  • 06971674867661 ()


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

BIOBASE - 06971674867654

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:100mL×1 R2:20mL×1
In Commercial Distribution

  • 06971674867654 ()


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

BIOBASE - 06971674867647

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:50mL×2 R2:10mL×2
In Commercial Distribution

  • 06971674867647 ()


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

BIOBASE - 06971674867630

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:25mL×1 R2:5mL×1
In Commercial Distribution

  • 06971674867630 ()


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

BIOBASE - 06971674867623

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:25mL×4 R2:5mL×4
In Commercial Distribution

  • 06971674867623 ()


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

BIOBASE - 06971674867616

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:12mL×2
In Commercial Distribution

  • 06971674867616 ()


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

BIOBASE - 06971674867609

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:70mL×2 R2:14mL×2
In Commercial Distribution

  • 06971674867609 ()


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

NovaLisa Echinococcus IgG - ENTIECHG01300

The Echinococcus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Echinococcus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ECHG0130
In Commercial Distribution

  • ENTIECHG01300 ()
ECHG0130

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

N/A - 00382903407613

BD® Mouse IgG1 (X40) PE
Becton, Dickinson And Company
340761
In Commercial Distribution

  • 00382903407613 ()
340761

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

Trinity Biotech - 05391516747547

B. burgdorferi Wash Buffer (10x)
CLARK LABORATORIES, INC.
40-1013
In Commercial Distribution

  • 05391516747547 ()

  • Total Volume: 100 Milliliter
40-1013

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

Horizon - 00382906594594

BD Horizon Mouse IgG1 (X40) BV510 ASR
Becton, Dickinson And Company
659459
In Commercial Distribution

  • 00382906594594 ()
659459

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

Horizon - 00382906577214

BD Horizon™ Mouse IgG1 (X40) BV605
Becton, Dickinson And Company
657721
In Commercial Distribution

  • 00382906577214 ()
657721

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

N/A - 00382903407606

Ms IgG1 Platelet Control PE X40 ASR
Becton, Dickinson And Company
340760
In Commercial Distribution

  • 00382903407606 ()
340760

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

N/A - 00382903407552

Ms IgG1 Isotype Control FITC X40 ASR
Becton, Dickinson And Company
340755
In Commercial Distribution

  • 00382903407552 ()
340755

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

N/A - 00382903391967

Ms IgG1 Isotype Control AmCyan X40 ASR
Becton, Dickinson And Company
339196
In Commercial Distribution

  • 00382903391967 ()
339196

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

Horizon - 00382906577092

BD Horizon™ Mouse IgG1 (X40) APC-R700
Becton, Dickinson And Company
657709
In Commercial Distribution

  • 00382906577092 ()
657709

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

N/A - 00382906414106

BD® Mouse IgG1 (X40) APC-H7
Becton, Dickinson And Company
641410
In Commercial Distribution

  • 00382906414106 ()
641410

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

N/A - 00382903407668

BD® Mouse IgG2a (X39) PE
Becton, Dickinson And Company
340766
In Commercial Distribution

  • 00382903407668 ()
340766

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

N/A - 00382903407620

BD® Mouse IgG1 (X40) PerCP
Becton, Dickinson And Company
340762
In Commercial Distribution

  • 00382903407620 ()
340762

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

N/A - 00382903407576

BD® Mouse IgG2a (X39) APC
Becton, Dickinson And Company
340757
In Commercial Distribution

  • 00382903407576 ()
340757

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

Trinity Biotech - 05391516747721

10x Wash Solution, 100 mL
MARDX DIAGNOSTICS, INC.
40-1013
In Commercial Distribution

  • 05391516747721 ()
40-1013

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-EA IgG Smart Kit Test System - 00845533000543

The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG 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. This test is intended for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
SM9Z9481G
In Commercial Distribution

  • 00845533000543 ()
SM9Z9481G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-EA IgG Q Test System - 00845533000536

The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG 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. This test is intended for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
Q9Z9481G
In Commercial Distribution

  • 00845533000536 ()
Q9Z9481G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-EA IgG Test System - 00845533000529

The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG 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. This test is intended for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
9Z9481G
In Commercial Distribution

  • 00845533000529 ()
9Z9481G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

IFA EBV-EA IgG Methanol Test System - 00845533001618

The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
FA9150ML
In Commercial Distribution

  • 00845533001618 ()
FA9150ML

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA EBV-EA IgG (Zorba) Test System - 00845533001601

The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
FA9150L
In Commercial Distribution

  • 00845533001601 ()
FA9150L

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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