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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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Bio-Rad Laboratories, Inc. - 00847865011273

Anti-Borrelia (Lyme) EIA , Substrate Concentrate
Bio-RAD Laboratories, Inc.
25276
In Commercial Distribution

  • 00847865011273 ()

  • Total Volume: 1.5 Milliliter
25276

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

Bio-Rad Laboratories, Inc. - 00847865011266

Anti-Borrelia (Lyme) EIA, Substrate Buffer
Bio-RAD Laboratories, Inc.
25275
In Commercial Distribution

  • 00847865011266 ()

  • Total Volume: 25 Milliliter
25275

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

Bio-Rad Laboratories, Inc. - 00847865011259

Anti-Borrelia (Lyme) EIA, Wash Buffer Concentrate [20X]
Bio-RAD Laboratories, Inc.
25273
In Commercial Distribution

  • 00847865011259 ()

  • Total Volume: 50 Milliliter
25273

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

Bio-Rad Laboratories - 00847865011167

Diluent for VCA IgG EIA Tests
Bio-RAD Laboratories, Inc.
25189
In Commercial Distribution

  • 00847865011167 ()

  • Total Volume: 25 Milliliter
25189

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

Bio-Rad Laboratories - 00847865010795

EB VCA IgG EIA
Bio-RAD Laboratories, Inc.
25184
In Commercial Distribution

  • 00847865010795 ()

  • 96 Tests
25184

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

Bio-Rad Laboratories - 00847865010788

EB NA IgG EIA
Bio-RAD Laboratories, Inc.
25183
In Commercial Distribution

  • 00847865010788 ()

  • 96 Tests
25183

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

Bio-Rad Laboratories, Inc. - 00847865001274

Anti-Borrelia (Lyme) Microplate EIA
Bio-RAD Laboratories, Inc.
32507
In Commercial Distribution

  • 00847865001274 ()

  • 96 Tests
32507

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

C6 B. burgdorferi (Lyme) ELISA - 00863782000305

No Description
IMMUNETICS, INC.
DK-E352-096
In Commercial Distribution

  • 00863782000305 ()


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

Histofluor® Rodent LKS Fluorescent Antibody Test System - M749120750211

Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 23ml.
IMMUNO CONCEPTS INC
12075-02 (1)
In Commercial Distribution

  • M749120750211 ()
12075-02 (1)

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

Histofluor® Rodent LKS Fluorescent Antibody Test System - M749120090211

Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 9ml.
IMMUNO CONCEPTS INC
12009-02 (1)
In Commercial Distribution

  • M749120090211 ()
12009-02 (1)

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

ANCA Test System - M749100091111

ANCA IgG Fluorescent Antibody Reagent - 1 x 9 mls.
IMMUNO CONCEPTS INC
10009-11 (1)
In Commercial Distribution

  • M749100091111 ()
10009-11 (1)

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

Horizon - 00382906645371

BD Horizon Mouse IgG1 (X40) BV786 ASR
Becton, Dickinson And Company
664537
In Commercial Distribution

  • 00382906645371 ()
664537

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

FREND COVID-19 total Ab - 08809317540924

The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.
NanoEnTek, Inc.
FREND COVID-19 total Ab
In Commercial Distribution

  • 08809317540924 ()
FRCOA 020

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Horizon - 00382906645265

BD Horizon Mouse IgG1 (X40) BV711 ASR
Becton, Dickinson And Company
664526
In Commercial Distribution

  • 00382906645265 ()
664526

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

Horizon - 00382906594532

BD Horizon™ Mouse IgG1 (X40) BV421
Becton, Dickinson And Company
659453
In Commercial Distribution

  • 00382906594532 ()
659453

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

Horizon - 00382906474520

BD Horizon Mouse IgG1 (X40) V500-C ASR
Becton, Dickinson And Company
647452
In Commercial Distribution

  • 00382906474520 ()
647452

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

Horizon - 00382906422774

BD Horizon™ Mouse IgG1 (X40) V450
Becton, Dickinson And Company
642277
In Commercial Distribution

  • 00382906422774 ()
642277

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

N/A - 00382903488025

BD® Mouse IgG1 (X40) APC-Cy7
Becton, Dickinson And Company
348802
In Commercial Distribution

  • 00382903488025 ()
348802

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

N/A - 00382903487981

Ms IgG1 Isotype Control PE-Cy7 X40 ASR
Becton, Dickinson And Company
348798
In Commercial Distribution

  • 00382903487981 ()
348798

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

N/A - 00382903472123

BD® Mouse IgG1 (X40) PerCP-Cy5.5
Becton, Dickinson And Company
347212
In Commercial Distribution

  • 00382903472123 ()
347212

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

N/A - 00382903407651

Ms IgG2a Isotype Control PerCP X39 ASR
Becton, Dickinson And Company
340765
In Commercial Distribution

  • 00382903407651 ()
340765

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

N/A - 00382903407644

Ms IgG2a Isotype Control FITC X39 ASR
Becton, Dickinson And Company
340764
In Commercial Distribution

  • 00382903407644 ()
340764

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

N/A - 00382903407569

Ms IgG2a Isotype Control PE X39 ASR
Becton, Dickinson And Company
340756
In Commercial Distribution

  • 00382903407569 ()
340756

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

N/A - 00382903407545

Ms IgG1 Isotype Control APC X40 ASR
Becton, Dickinson And Company
340754
In Commercial Distribution

  • 00382903407545 ()
340754

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

VIDAS® Lyme IgG and IgM - 03573026156879

The VIDAS ® Lyme IgG and IgM assay for use on VIDAS family instruments for the presumptive detection of total antibodies (IgG/IgM) to Borrelia burgdorferi
BIOMERIEUX SA
30298-01
Not in Commercial Distribution

  • 03573026156879 ()


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

Bio-Rad - 03610522051243

EBV EA-D IgG EIA TEST
Bio-RAD Laboratories, Inc.
12008530
In Commercial Distribution

  • 03610522051243 ()

  • 96 Tests
12008530

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

BioPlex 2200 - 03610520506462

BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

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

BioPlex 2200 - 03610520506455

U.S. IFU, Canada IFU (United States, Canada) Manual & CDs, BioPlex 2200 Lyme Total IFU SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506455 ()

  • 1 Each
12000882

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

BioPlex 2200 - 03610520506394

BioPlex 2200 Lyme Total 200 Tests
BIO-RAD LABORATORIES, INC.
12000876
In Commercial Distribution

  • 03610520506394 ()

  • 200 Tests
12000876

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

LIAISON Lyme Total Antibody Plus - 08056771602709

No Description
Diasorin Inc.
318330
In Commercial Distribution

  • 08056771602709 ()


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

LIAISON® Borrelia burgdorferi - 08056771600262

No Description
Diasorin Inc.
310870
In Commercial Distribution

  • 08056771600262 ()
  • 18056771600269 ()


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

LIAISON® VCA IgG - 08056771101714

No Description
DIASORIN SPA
310510
In Commercial Distribution

  • 08056771101714 ()


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

CHORUS ECHINOCOCCUS IgG - 08033891320010

No Description
DIESSE DIAGNOSTICA SENESE SPA
81284
In Commercial Distribution

  • 08033891320010 ()
81284

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

AccuDiag ™ - 00894175000022

AccuDiag ™ Borrelia burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
Diagnostic Automation, Inc.
DACD-1423-2
In Commercial Distribution

  • 00894175000022 ()

  • 96 tests
1423-2

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

Borrelia burgdorferi IgM (Lyme) ELISA - 00840239028112

The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM 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 International Inc
EIA-2811
In Commercial Distribution

  • 00840239028112 ()
EIA-2811

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

Borrelia burgdorferi IgG (Lyme) ELISA - 00840239028105

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 International Inc
EIA-2810
In Commercial Distribution

  • 00840239028105 ()
EIA-2810

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

B. burgdorferi IgG/IgM ELISA - 00840239028099

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 International Inc
EIA-2809
In Commercial Distribution

  • 00840239028099 ()
EIA-2809

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

RIDASCREEN® Echinococcus IgG - 04049095110511

The RIDASCREEN® Echinococcus IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Echinococcus granulosus und Echinococcus multilocularis in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Echinococcus.
R-Biopharm AG
K7621
Not in Commercial Distribution

  • 04049095110511 ()
K7621

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

Anti-Echinococcus ELISA (IgG) - 04049016117124

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2320-9601-1 G
In Commercial Distribution

  • 04049016117124 ()


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

Anti-Echinococcus EUROLINE WB (IgG) - 04049016116110

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2321-1601-1 G
In Commercial Distribution

  • 04049016116110 ()


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

Lyme ELISA (IgG/IgM) - 04049016114895

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2132-9601-24 O
In Commercial Distribution

  • 04049016114895 ()


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

Anti-Legionella pneumophila ELISA (IgG) - 04049016027515

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2150-9601 G
In Commercial Distribution

  • 04049016027515 ()


  • Legionella pneumophila immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

FITC-labelled anti-human IgG - 04049016151609

No Description
EUROIMMUN Medizinische Labordiagnostika AG
AF 102-0546-R
In Commercial Distribution

  • 04049016151609 ()


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

FITC-labelled anti-human IgG - 04049016151234

No Description
EUROIMMUN Medizinische Labordiagnostika AG
AF 102-0540-R
In Commercial Distribution

  • 04049016151234 ()


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

MERIFLUOR EBV-EA IgG IFA - 00840733103247

The MERIFLUOR EBV-EA IgG IFA Test is a sensitive and rapid immunofluorescence method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human serum. When performed according to instructions, the MERIFLUOR EBV-EA IgG IFA Test detects IgG antibodies to the diffuse (D) and restricted (R) components of the EBV-EA complex. It is of value in providing supportive information for the diagnosis of EBV associated disease.
MERIDIAN BIOSCIENCE, INC.
EA101
Not in Commercial Distribution

  • 00840733103247 ()
EA101

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

MERIFLUOR EBV VCA IgG IFA - 00840733101939

An immunofluorescence test for the detection of EBV VCA IgG Antibodies to Epstein-Barr Virus.
MERIDIAN BIOSCIENCE, INC.
EB100
Not in Commercial Distribution

  • 00840733101939 ()
EB100

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

MERIFLUOR GullSORB - 00840733101304

GullSORB is an antihuman IgG reagent used to eliminate IgG interference in human serum containing both IgM and IgG. This reagent has been standardized for use with IgM IFA assays manufactured by Meridian Bioscience, Inc.
MERIDIAN BIOSCIENCE, INC.
XX715
Not in Commercial Distribution

  • 00840733101304 ()
XX715

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

Legionella IFA Polyvalent Conjugate - 10816101020017

No Description
DIASORIN MOLECULAR LLC
IF0010
Not in Commercial Distribution

  • 10816101020017 ()


  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

FITC Anti-IgG Primary Antibody - 04015630971497

No Description
Ventana Medical Systems, Inc.
05267919001
In Commercial Distribution

  • 04015630971497 ()
05267919001

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

Borrelia burgdorferi IgM (Lyme) ELISA - 04048474028119

The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM 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-2811
In Commercial Distribution

  • 04048474028119 ()
EIA-2811

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