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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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Antistreptolysine O (ASO_2) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097634
In Commercial Distribution

  • 00630414596167 ()
11097634

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
ASLO - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10318208
In Commercial Distribution

  • 00630414517681 ()
3055483

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
VIROTROL WNV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00116
In Commercial Distribution

  • 00847661002628 ()
00116

  • West Nile virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
BioSign Flu A+B Nasopharyngeal Wash/Aspirate Kit, 50 pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-07
In Commercial Distribution

  • 10743816001485 ()
BSP-510AS-07

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
Gold Standard Diagnostics H. pylori ELISA IgA Test Kit
Gold Standard Diagnostics Corporation
GSD01-1001
Not in Commercial Distribution

  • B350GSD0110010 ()


  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
1625-300
In Commercial Distribution

  • 00816870021089 ()

  • Width: 7.75 Inch
1625-300A

  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08105472190
In Commercial Distribution

  • 07613336133545 ()
08105472190

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
The SeroELISAChlamydia IgA kit is intended for the determination of specific IgA antibodies to Chlamydia in a single human serum sample by an Enzyme-Linked Immunosorbent Assay (ELISA). For In Vitro Diagnostic Use.
SAVYON DIAGNOSTICS LTD
A113-01
In Commercial Distribution

  • 07290001913161 ()


  • Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Antistreptolysin-O Reagent (ASO- 2 x 100)
Beckman Coulter, Inc.
469165
In Commercial Distribution

  • 15099590232054 ()
469165

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
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