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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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Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446658
In Commercial Distribution

  • 00842768013317 ()
OWTI11

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent
Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446036
In Commercial Distribution

  • 00842768007200 ()
OQAI11

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Di(a+) Cell is used in the detection of unexpected red blood cell blood group antibodies. Di(a+) Cell is a single vial of group O, Di(a+) red blood cells.
IMMUCOR, INC.
0005021
In Commercial Distribution

  • 10888234000471 ()
0005021

  • Di^a positive reagent red blood cell IVD, antigen
Quantia ASO Calibrator
ABBOTT LABORATORIES
6K46-02
In Commercial Distribution

  • 00380740030056 ()
06K4602

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
Immunoglobulin A
ABBOTT LABORATORIES
9D98-21
In Commercial Distribution

  • 00380740019754 ()
09D9821

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
ARCHITECT HAVAB-G Controls
Abbott GmbH
6L27-10
In Commercial Distribution

  • 00380740011178 ()
06L2710

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, control
ARCHITECT HAVAB-G Calibrator
Abbott GmbH
6L27-01
In Commercial Distribution

  • 00380740011161 ()
06L2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
BD Horizon™ CD235a (GA-R2/HIR2) BV605
Becton, Dickinson And Company
666664
In Commercial Distribution

  • 00382906666642 ()
666664

  • CD235a glycophorin A red blood cell marker IVD, antibody
HAVAb IgG II Controls
Abbott GmbH
06S9310
In Commercial Distribution

  • 00380740197643 ()
06S9310

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, control
HAVAb IgG II Calibrator
Abbott GmbH
06S9301
In Commercial Distribution

  • 00380740197636 ()
06S9301

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
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