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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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AmpliVue - 30014613312123

AmpliVue GAS Assay
QUIDEL CORPORATION
Group A Strep Assay
Not in Commercial Distribution

  • 30014613312123 ()
M212

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Lyra - 30014613311126

Lyra Direct Strep Assay
QUIDEL CORPORATION
Direct Strep Assay
In Commercial Distribution

  • 30014613311126 ()
M112

  • Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)

Di(a+) Cell - 10888234000471

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

Horizon - 00382906666642

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

ARCHITECT - 00380740030056

Quantia ASO Calibrator
ABBOTT LABORATORIES
6K46-02
In Commercial Distribution

  • 00380740030056 ()
06K4602

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator

ARCHITECT - 00380740019754

Immunoglobulin A
ABBOTT LABORATORIES
9D98-21
In Commercial Distribution

  • 00380740019754 ()
09D9821

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

ARCHITECT - 00380740011178

ARCHITECT HAVAB-G Controls
Abbott GmbH
6L27-10
In Commercial Distribution

  • 00380740011178 ()
06L2710

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

ARCHITECT - 00380740011161

ARCHITECT HAVAB-G Calibrator
Abbott GmbH
6L27-01
In Commercial Distribution

  • 00380740011161 ()
06L2701

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

N/A - 00382903409464

CD235a (GA-R2/HIR2) ASR
Becton, Dickinson And Company
340946
In Commercial Distribution

  • 00382903409464 ()
340946

  • CD235a glycophorin A red blood cell marker IVD, antibody

Optilite Hevylite® IgA Lambda Kit - 05051700018494

No Description
THE BINDING SITE GROUP LIMITED
NK624.OPT.A
In Commercial Distribution

  • 05051700018494 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
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