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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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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.
G7700S-001
In Commercial Distribution

  • 00657498000397 ()
G7700S-001

  • Multiple clinical chemistry analyser IVD, laboratory, semi-automated
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
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.
STANBIO LABORATORY, L.P.
401010
In Commercial Distribution

  • 00657498000090 ()
  • 00657498001868 ()
401010

  • Single-channel clinical chemistry analyser IVD, point-of-care
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.
400400
In Commercial Distribution

  • 00657498000083 ()
400400

  • Single-channel clinical chemistry analyser IVD, point-of-care
The Uri-Trak™ 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek™ and Uri-Con™ 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only.
STANBIO LABORATORY, L.P.
G1200-001
In Commercial Distribution

  • 00657498000076 ()
G1200-001

  • Urine analyser IVD, laboratory
The Stanbio Uri-Chek™ 10SG Urinalysis Reagent Strips are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes.
STANBIO LABORATORY, L.P.
1280-100
In Commercial Distribution

  • 00657498000052 ()
  • 00657498000069 ()
1280-100

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
POS-T-VAC INC
Cone White
In Commercial Distribution

  • 00656535000536 ()
J110

  • Penile vacuum device
No Description
POS-T-VAC INC
Cone Grey
In Commercial Distribution

  • 00656535000529 ()
V114

  • Penile vacuum device
FPA,312,FX,L,DBR,MF,GG30-DWTHP
Gn Hearing A/S
21276906
In Commercial Distribution

  • 05708296185528 ()


  • Air-conduction hearing aid, canal
FPA,312,FX,L,BGE,MF,GG30-DWTHP
Gn Hearing A/S
21276904
In Commercial Distribution

  • 05708296185504 ()


  • Air-conduction hearing aid, canal
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