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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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Detector Strep A - 10722355001668

A qualitative immunoassay for the detection of Strep A Antigen from direct throat swab
Immunostics Company, Inc
IST-501-OBC33
In Commercial Distribution

  • 20722355001665 ()
  • 10722355001668 ()
  • 30722355001662 ()
  • 80722355001667 ()
IDSTREP-25

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

JAS Diagnostics - 00817274021774

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
XL-A1C2-30
In Commercial Distribution

  • 00817274021774 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021767

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
A1C2-30
In Commercial Distribution

  • 00817274021767 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021750

HEMOGLOBIN A1C REAGENT (1x 30mL R1, 1x 9.5mL R2a, 1x 0.5mL R2b
DREW SCIENTIFIC, INC.
A1C2-30A
In Commercial Distribution

  • 00817274021750 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

Rapid Response - 10722066006846

Rapid Response Strep A Test (Throat Swab) - for the qualitative detection of Streptococcus pyogenes (Strep A) antigens from throat swab specimens. For professional, prescription in vitro diagnostic use.
BTNX Inc
STA-15S25
In Commercial Distribution

  • 00722066006849 ()
  • 10722066006846 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Nano-Check TM Strep A Test - 00895160002687

A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection
NANO-DITECH CORPORATION
MD8148
In Commercial Distribution

  • 10895160002684 ()
  • 00895160002687 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

ETI-AB-HAVK PLUS - 08056771102315

No Description
DIASORIN SPA
P001926
In Commercial Distribution

  • 08056771102315 ()


  • Hepatitis A virus total antibody IVD, kit, enzyme immunoassay (EIA)

Toxoplasma gondii RPab - B502BSB60480

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

Toxoplasma gondii RPab - B502BSB60470

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

Toxoplasma gondii RPab - B502BSB60460

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
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