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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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EBV-VCA IgG
CLARK LABORATORIES, INC.
72937
In Commercial Distribution

  • 05391516746557 ()

  • 96 Tests
72937

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
FTA-ABS, 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
31-8010
In Commercial Distribution

  • 05391516746397 ()
31-8010

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi EIA (IgG, IgM) Test System (480 Tests)
MARDX DIAGNOSTICS, INC.
40-8696P/J
In Commercial Distribution

  • 05391516746304 ()
40-8696P/J

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi EIA (IgG, IgM) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696P
In Commercial Distribution

  • 05391516746298 ()
40-8696P

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Legionella IFA Test System, (L. pneumophila, serogroups 1-6), 120 Tests
MARDX DIAGNOSTICS, INC.
30-7120
In Commercial Distribution

  • 05391516746151 ()
30-7120

  • Legionella pneumophila immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBNA-1 IgG
CLARK LABORATORIES, INC.
2325800
In Commercial Distribution

  • 05391516743570 ()

  • 96 Tests
2325800

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV EA-D IgG
CLARK LABORATORIES, INC.
2325000
In Commercial Distribution

  • 05391516743365 ()

  • 96 Tests
2325000

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV VCA P-18 IgG
CLARK LABORATORIES, INC.
2324700
In Commercial Distribution

  • 05391516743334 ()

  • 96 Tests
2324700

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007180 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007371 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QMedix™ EBV VCA IgG ImmunoFlourescent Assay
Diagnostic Automation, Inc.
DACD401010-G
In Commercial Distribution

  • 00850054026613 ()

  • 10, 10-well slides
401010-G

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
QMedix™ Lyme IgG/IgM ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1423-55
In Commercial Distribution

  • 00850054026378 ()

  • 96 Tests
1423-55

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
FITC anti-IgG Goat Polyclonal Antibody, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8535-M250
In Commercial Distribution

  • 00615233010575 ()
8535-M250

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
FITC anti-IgG Goat Polyclonal Antibody, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8535-C010
In Commercial Distribution

  • 00615233002303 ()
8535-C010

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Anti-Borrelia (Lyme) EIA, Conjugate
Bio-RAD Laboratories, Inc.
25274
In Commercial Distribution

  • 00847865011495 ()

  • Total Volume: 12 Milliliter
25274

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Borrelia Blocker
Bio-RAD Laboratories, Inc.
25272
In Commercial Distribution

  • 00847865011488 ()

  • Total Volume: 25 Milliliter
25272

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Positive Control
Bio-RAD Laboratories, Inc.
25271
In Commercial Distribution

  • 00847865011471 ()

  • Total Volume: 0.1 Milliliter
25271

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Negative Control
Bio-RAD Laboratories, Inc.
25270
In Commercial Distribution

  • 00847865011464 ()

  • Total Volume: 0.3 Milliliter
25270

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA Calibrator
Bio-RAD Laboratories, Inc.
25269
In Commercial Distribution

  • 00847865011457 ()

  • Total Volume: 0.3 Milliliter
25269

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Stop Solution
Bio-RAD Laboratories, Inc.
25277
In Commercial Distribution

  • 00847865011280 ()

  • Total Volume: 25 Milliliter
25277

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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)
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)
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)
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)
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)
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)
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)
No Description
IMMUNETICS, INC.
DK-E352-096
In Commercial Distribution

  • 00863782000305 ()


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