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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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No Description
Roche Diagnostics GmbH
11876376160
Not in Commercial Distribution

  • 04015630934843 ()
11876376160

  • Hepatitis B virus e-antigen IVD, control
No Description
Roche Diagnostics GmbH
11876317160
Not in Commercial Distribution

  • 04015630910908 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 04015630999286 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
07251076190
Not in Commercial Distribution

  • 04015630940028 ()
07251076190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04927931160
Not in Commercial Distribution

  • 04015630923045 ()
04927931160

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
04927826160
Not in Commercial Distribution

  • 04015630923038 ()
04927826160

  • Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay
Anti-HBs EIA, Conjugate Diluent 15 mL
Bio-RAD Laboratories, Inc.
26155
In Commercial Distribution

  • 00847865002103 ()

  • Total Volume: 15 Milliliter
26155

  • Hepatitis B virus surface total antibody IVD, reagent
HBsAg EIA 3.0 Conjugate Diluent, 120 mL
Bio-RAD Laboratories, Inc.
25104
In Commercial Distribution

  • 00847865001861 ()

  • Total Volume: 120 Milliliter
25104

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
Marblot Bordetella IgG PLUS, Western Blot System for the Detection of IgG Antibodies to Bordetella pertussis, 40 Tests
MARDX DIAGNOSTICS, INC.
40-6020P
In Commercial Distribution

  • 05391516746311 ()
40-6020P

  • Bordetella pertussis total antibody IVD, kit, immunoblot
B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordetella pertussis PT and FHA, 96 Tests
MARDX DIAGNOSTICS, INC.
40-6196P
In Commercial Distribution

  • 05391516747899 ()
40-6196P

  • Bordetella pertussis total antibody IVD, kit, immunoblot
B. pertussis WB Negative Control, 250 µL
MARDX DIAGNOSTICS, INC.
40-6111
In Commercial Distribution

  • 05391516747882 ()
40-6111

  • Bordetella pertussis total antibody IVD, control
B. pertussis WB Positive IgG Control, 250 µL
MARDX DIAGNOSTICS, INC.
40-6025
In Commercial Distribution

  • 05391516747875 ()
40-6025

  • Bordetella pertussis total antibody IVD, control
Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 9 mL
MARDX DIAGNOSTICS, INC.
40-6055G
In Commercial Distribution

  • 05391516747868 ()
40-6055G

  • Bordetella pertussis total antibody IVD, reagent
Immunoassay for the detection of IgG antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSGOK
In Commercial Distribution

  • EVIRBPSGOK1 ()

  • 50 tests
V-BPSGOK

  • Bordetella pertussis total antibody IVD, kit, immunoblot
Immunoassay for the detection of IgG antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSGDK
In Commercial Distribution

  • EVIRBPSGDK1 ()

  • 500 tests
V-BPSGDK

  • Bordetella pertussis total antibody IVD, kit, immunoblot
Immunoassay for the detection of IgA antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSAOK
In Commercial Distribution

  • EVIRBPSAOK1 ()

  • 50 tests
V-BPSAOK

  • Bordetella pertussis total antibody IVD, kit, immunoblot
Immunoassay for the detection of IgA antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSADK
In Commercial Distribution

  • EVIRBPSADK1 ()

  • 500 tests
V-BPSADK

  • Bordetella pertussis total antibody IVD, kit, immunoblot
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 M
Not in Commercial Distribution

  • 04049016096047 ()


  • Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-24001 A
Not in Commercial Distribution

  • 04049016085461 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
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)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-1601 A
Not in Commercial Distribution

  • 04049016085430 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 A
Not in Commercial Distribution

  • 04049016085492 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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)
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)
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)
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 International Inc
EIA-3450
In Commercial Distribution

  • 00840239034502 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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 International Inc
EIA-6133
Not in Commercial Distribution

  • 00840239061331 ()
EIA-6133

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