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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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EY-20(TM) Reagent Tube - 00863251000232

The EY-20™ Reagent Tubes are a component of the Strep-A-Chek™ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chek™ Reagent Strips. They are intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta hemolytic colonies grown on blood agar plates, as an aid in the presumptive identification of Group A Streptococcus. EY-20™ Reagent Tubes contain a color developer, which when used with the Strep-A-Chek™ Reagent Strips detect pyrrolidonyl arylamidase (PYR), an enzyme present in Group A beta-hemolytic Streptococcus. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. The Strep-A-Chek™ test system, when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of streptococci or enterococci from any source.
E-Y Laboratories, Inc.
13-020-50
In Commercial Distribution

  • 00863251000232 ()
13-020-50

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

Strep-A-Chek(TM) Strips (100 pcs) - 00863251000225

Strep-A-Chek™ Reagent Strips are paper strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl arylamidase (PYR), an enzyme reported to be present in Group A beta-hemolytic Streptococcus. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. Strep-A-Chek™ kit when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of beta-hemolytic streptococci or enterococci from any source. Strep-A-Chek™ Reagent Strips are a component of the Strep-A-Chek™ Kit (Cat. No: 13-050-00) and are to be used with EY-20™ Reagent Tubes. They are intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on blood agar plates, as an aid in the presumptive identification of Group A Streptococcus.
E-Y Laboratories, Inc.
13-051-00
In Commercial Distribution

  • 00863251000225 ()
13-051-00

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

Strep-A-Chek(TM) Kit - 00863251000201

Strep-A-Chek™ Kit is intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on blood agar plates, as an aid in the presumptive identification of Group A Streptococcus. Strep-A-Chek™ consists of Strep-A-Chek™ Reagent Strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl arylamidase (PYR), an enzyme reported to be present in Group A beta-hemolytic Streptococcus, and EY-20™ Reagent Tubes which contain a diazo dye color developer, Fast Garnet. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. Strep-A-Chek™ Kit when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of beta-hemolytic streptococci or enterococci from any source.
E-Y Laboratories, Inc.
13-050-00
In Commercial Distribution

  • 00863251000201 ()
13-050-00

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

QuSTICK™ Strep A - 00657498600016

A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.
STANBIO LABORATORY, L.P.
6000-025
In Commercial Distribution

  • 00657498600016 ()
  • 00657498600030 ()
6000-025

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

QuSTICK™ Strep A - 00657498600023

A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.
STANBIO LABORATORY, L.P.
6000-050
In Commercial Distribution

  • 00657498600023 ()
  • 00657498600047 ()
6000-050

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

ARCHITECT - 00380740001315

ARCHITECT Cyclosporine Reagent Kit
ABBOTT LABORATORIES
1L75-25
In Commercial Distribution

  • 00380740001315 ()
01L7525

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Anti-SARS-CoV-2 ELISA (IgA) - 04049016145547

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601 A
Not in Commercial Distribution

  • 04049016145547 ()


  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Candida albicans IFA (IgA) - 04049016067801

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-2005 A
Not in Commercial Distribution

  • 04049016067801 ()


  • Candida albicans immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay

Anti-Candida albicans IFA (IgA) - 04049016067788

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-1005 A
Not in Commercial Distribution

  • 04049016067788 ()


  • Candida albicans immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay

Anti-Mycoplasma pneumoniae IFA (IgA) - 04049016055112

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-1005 A
Not in Commercial Distribution

  • 04049016055112 ()


  • Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay
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