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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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Bordetella pertussis Toxin (PT) IgG ELISA - 04048474061338

The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6133
Not in Commercial Distribution

  • 04048474061338 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA - 04048474034509

The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3450
In Commercial Distribution

  • 04048474034509 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA - 00404847434507

The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in 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-3450
Not in Commercial Distribution

  • 00404847434507 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis Toxin (PT) IgG ELISA - 00404847461336

The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6133
Not in Commercial Distribution

  • 00404847461336 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/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

IFA EBV-EA IgG Test System - 00845533001595

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.
FA9152
In Commercial Distribution

  • 00845533001595 ()
FA9152

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

Echovirus Negative Control - B110ECN44100

No Description
Bion Enterprises, Ltd.
ECN-4410
Not in Commercial Distribution

  • B110ECN44100 ()
ECN-4410

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

Echovirus IgG Control - B110ECG44200

No Description
Bion Enterprises, Ltd.
ECG-4420
Not in Commercial Distribution

  • B110ECG44200 ()
ECG-4420

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pk - 00813545026066

No Description
SCIMEDX CORPORATION
I-OTS01X
In Commercial Distribution

  • 00813545026066 ()
I-OTS01X

  • Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Ehrlichia chaffeensis 12wl; 10 pk - 00813545025649

No Description
SCIMEDX CORPORATION
I-ECH01X
In Commercial Distribution

  • 00813545025649 ()
I-ECH01X

  • Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

EBV EA 10 Well; 10 pk - 00813545025618

No Description
SCIMEDX CORPORATION
I-EBV03X
In Commercial Distribution

  • 00813545025618 ()
I-EBV03X

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

EBV-EA IgG 120 Test Kit - 00813545025595

No Description
SCIMEDX CORPORATION
I-EBV03G
In Commercial Distribution

  • 00813545025595 ()
I-EBV03G

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

ACS - 00191072047618

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
JRET18G
In Commercial Distribution

  • 00191072047618 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072043405

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
HECY92O
In Commercial Distribution

  • 00191072043405 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072003430

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01I
In Commercial Distribution

  • 00191072003430 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072061553

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01J
In Commercial Distribution

  • 00191072061553 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072234322

CYSTO PK| STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01S
In Commercial Distribution

  • 00191072234322 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072071545

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01K
In Commercial Distribution

  • 00191072071545 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072091468

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01N
In Commercial Distribution

  • 00191072091468 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072199287

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01R
In Commercial Distribution

  • 00191072199287 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072184757

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01Q
In Commercial Distribution

  • 00191072184757 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072108289

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01O
In Commercial Distribution

  • 00191072108289 ()


  • General surgical procedure kit, non-medicated, single-use

IMMUNO CONCEPTS - M7490081311

Custom - EBNA FA BP - 3900 wells
IMMUNO CONCEPTS INC
8131
In Commercial Distribution

  • M7490081311 ()
8131

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

Trinity Biotech - 05391516747820

Legionella IFA Test System,(Legionella species), 180 Tests
MARDX DIAGNOSTICS, INC.
30-7980
In Commercial Distribution

  • 05391516747820 ()
30-7980

  • Legionella longbeachae immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516747622

B. burgdorferi WB IgG Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2023L
In Commercial Distribution

  • 05391516747622 ()
40-2023L

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516747202

Captia™ Legionella pneumophila IgG/IgM
CLARK LABORATORIES, INC.
2346980
In Commercial Distribution

  • 05391516747202 ()

  • 96 Tests
2346980

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007364

Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB NA G
In Commercial Distribution

  • 00850487007364 ()
Q01-460

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

ReQuest - 00850487007166

Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB NA G
In Commercial Distribution

  • 00850487007166 ()
Q01-460

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

EBV-EA IgG ELISA - 00840239027962

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. The performance characteristics have not been established to aid in the diagnosis of acute IM.
DRG International Inc
EIA-2796
Not in Commercial Distribution

  • 00840239027962 ()
EIA-2796

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

Epstein Barr Virus VCA IgG ELISA - 00840239027931

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 International Inc
EIA-2793
Not in Commercial Distribution

  • 00840239027931 ()
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

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)

ELISA L. pneumophila IgG/IgM/IgA Smart Kit Test System - 00845533000796

The ZEUS ELISA Legionella pneumophila IgG/IgM/IgA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of total antibody (IgG/IgM/IgA) to Legionella pneumophila serogroups 1-6 in human sera. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM3Z15051
In Commercial Distribution

  • 00845533000796 ()
SM3Z15051

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA L. pneumophila IgG/IgM/IgA Test System - 00845533000789

The ZEUS ELISA Legionella pneumophila IgG/IgM/IgA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of total antibody (IgG/IgM/IgA) to Legionella pneumophila serogroups 1-6 in human sera. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z15051
In Commercial Distribution

  • 00845533000789 ()
3Z15051

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-VCA IgG Smart Kit Test System - 00845533000482

The ZEUS ELISA 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, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9201G
In Commercial Distribution

  • 00845533000482 ()
SM9Z9201G

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