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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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A & A KNEE PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJHS0136D
In Commercial Distribution

  • 10889942848973 ()
  • 40889942848974 ()
DYNJHS0136D

  • General surgical procedure kit, non-medicated, single-use
A & A KNEE PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJHS0136F
In Commercial Distribution

  • 40198459174255 ()
  • 10198459174254 ()
DYNJHS0136F

  • General surgical procedure kit, non-medicated, single-use
STERILE A A PACK
Cardinal Health 200, LLC
SOP24AAJRD
In Commercial Distribution

  • 50887488327233 ()
  • 10887488327235 ()
SOP24AAJRD

  • Orthopaedic surgical procedure kit, non-medicated, single-use
KNEE A & A CDS-LF
MEDLINE INDUSTRIES, INC.
CDS940088M
In Commercial Distribution

  • 10888277890169 ()
  • 40888277890160 ()
CDS940088M

  • General surgical procedure kit, non-medicated, single-use
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™ 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™ 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
SURE-VUE STREP A 27/PK
FISHER SCIENTIFIC COMPANY L.L.C.
4581455021
In Commercial Distribution

  • 00613647000557 ()
  • 10613647000554 ()
23900532

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Sure-Vue Signature Strep A
FISHER SCIENTIFIC COMPANY L.L.C.
23-200-276
In Commercial Distribution

  • 20613647000292 ()
  • 00613647000298 ()
  • 10613647000295 ()
23200276

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Cyclosporine - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10335448
In Commercial Distribution

  • 00630414524450 ()
4564446

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