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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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10-Strip; Strep A Throat Swab Test
WONDFO USA CO., LTD.
PRE-STA-10
In Commercial Distribution

  • 10816862023722 ()
  • 00816862023725 ()
  • 00816862023732 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1029
Not in Commercial Distribution

  • B350GSD0110290 ()
GSD01-1029

  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
One Step+ Strep A Dipstick 50 Test
HENRY SCHEIN, INC.
5700122
In Commercial Distribution

  • 20304040024168 ()
  • 10304040024161 ()
  • 00304040024164 ()
5700122

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
One Step+ Strep A Dipstick 25 Test
HENRY SCHEIN, INC.
1074050
In Commercial Distribution

  • 20304040024144 ()
  • 10304040024147 ()
  • 00304040024140 ()
1074050

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
One Step Pro Strep A Cassette
HENRY SCHEIN, INC.
9007570
In Commercial Distribution

  • 20304040053243 ()
  • 10304040053246 ()
  • 00304040053249 ()
9007570

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB60480 ()
BSB 6048

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB60470 ()
BSB 6047

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB60460 ()
BSB 6046

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB60450 ()
BSB 6045

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB60440 ()
BSB 6044

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
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