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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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Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Siemens Healthcare Diagnostics Products GmbH
10445984
In Commercial Distribution

  • 00842768006807 ()
  • 00842768019241 ()
OPBU05

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Siemens Healthcare Diagnostics Products GmbH
10445983
In Commercial Distribution

  • 00842768006791 ()
  • 00842768019258 ()
OPBU03

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of antistreptolysin O in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445888
In Commercial Distribution

  • 00842768006036 ()
  • 00842768019944 ()
K7022

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Cyclosporine Extended Range Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444934
Not in Commercial Distribution

  • 00842768005268 ()
  • 00630414004198 ()
DF108

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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
RHEIN 83 SRL
OT EQUATOR GL Impl/System C-TECH h.4
Not in Commercial Distribution

  • D821130CTH4 ()
VE057

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Chemistry Products ASO Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6802218
In Commercial Distribution

  • 10758750002306 ()
  • 20758750002303 ()
6802218

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