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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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Xpert Xpress Strep A kit; 120 test kit
CEPHEID
XPRSTREPA-120
In Commercial Distribution

  • 07332940002503 ()
XPRSTREPA-120

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana Strep A/C & G Assay
DIAGNOSTIC HYBRIDS, INC.
M305
In Commercial Distribution

  • 30014613336136 ()
M305

  • Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana GAS Assay
QUIDEL CORPORATION
Group A Strep Assay
In Commercial Distribution

  • 30014613336082 ()
M301

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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 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)
No Description
DIASORIN MOLECULAR LLC
MOL2850
In Commercial Distribution

  • 20816101025569 ()
MOL2850

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
VIROTROL HAV-IgM (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00142A
In Commercial Distribution

  • 00847661005704 ()
00142A

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873691
In Commercial Distribution

  • 00630414285054 ()
OWTI15

  • 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
10873689
In Commercial Distribution

  • 00630414285030 ()
OQAI15

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
BIOCARE MEDICAL LLC
OPAI3272T60
In Commercial Distribution

  • 00847627028563 ()


  • CD235a glycophorin A red blood cell marker IVD, antibody
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