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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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FPA,10A,L,LHT,MFI,GG10-W HP
Gn Hearing A/S
21233900
In Commercial Distribution

  • 05708296180745 ()


  • Air-conduction hearing aid, canal
FPA,10A,R,MBR,MFI,GG10-W MP
Gn Hearing A/S
21233805
In Commercial Distribution

  • 05708296180721 ()


  • Air-conduction hearing aid, canal
FPA,10A,R,BGE,MFI,GG10-W MP
Gn Hearing A/S
21233804
In Commercial Distribution

  • 05708296180714 ()


  • Air-conduction hearing aid, canal
FPA,10A,R,LHT,MFI,GG10-W MP
Gn Hearing A/S
21233800
In Commercial Distribution

  • 05708296180691 ()


  • Air-conduction hearing aid, canal
FPA,10A,L,DRK,MFI,GG10-W MP
Gn Hearing A/S
21233702
In Commercial Distribution

  • 05708296180653 ()


  • Air-conduction hearing aid, canal
The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
STANBIO LABORATORY, L.P.
7020-050
In Commercial Distribution

  • 00657498002247 ()
  • 00657498002223 ()
7020-050

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Ketone Urine Controls is an assayed urine control intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic Acid, Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specify Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and human Chorionic Gonadotropin.
STANBIO LABORATORY, L.P.
4020-005
In Commercial Distribution

  • 00657498002162 ()
4020-005

  • Multiple urine analyte IVD, control
Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood.
STANBIO LABORATORY, L.P.
4000-100
In Commercial Distribution

  • 00657498002131 ()
  • 00657498002148 ()
4000-100

  • Ketone (acetoacetate) IVD, reagent
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
STANBIO LABORATORY, L.P.
401020
In Commercial Distribution

  • 00657498000731 ()
401020

  • Single-channel clinical chemistry analyser IVD, point-of-care
This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application.
STANBIO LABORATORY, L.P.
G7700E-001
In Commercial Distribution

  • 00657498000380 ()
G7700E-001

  • Multiple clinical chemistry analyser IVD, laboratory, semi-automated
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