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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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For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
STANBIO LABORATORY, L.P.
3025-050
In Commercial Distribution

  • 00657498000236 ()
  • 00657498001455 ()
3025-050

  • Haemoglobin analyser IVD, point-of-care
The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents.
STANBIO LABORATORY, L.P.
G3500-001
Not in Commercial Distribution

  • 00657498000199 ()
G3500-001

  • Haemoglobin analyser IVD, point-of-care
The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting.
STANBIO LABORATORY, L.P.
901010
Not in Commercial Distribution

  • 00657498000175 ()
901010

  • Haemoglobin analyser IVD, point-of-care
The Stanbio STAT-Site® MHgb Test Kit is intended for the quantitative determination of hemoglobin in whole blood using the Stanbio STAT-Site® MHgb Meter. The STAT-Site® MHgb Test may be used with adults, infants, and children in a physician’s office or other professional point-of-care setting.
STANBIO LABORATORY, L.P.
901025
Not in Commercial Distribution

  • 00657498000151 ()
  • 00657498001820 ()
901025

  • Haemoglobin analyser IVD, point-of-care
The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting.
STANBIO LABORATORY, L.P.
900900
Not in Commercial Distribution

  • 00657498000144 ()
900900

  • Haemoglobin analyser IVD, point-of-care
The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents.
STANBIO LABORATORY, L.P.
G3000-CONTCUV
In Commercial Distribution

  • 00657498300039 ()
G3000-CONTCUV

  • Haemoglobin analyser IVD, point-of-care
For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-3013-0369
In Commercial Distribution

  • 24048534001964 ()
  • 14048534001967 ()
  • 04048534001953 ()
900-500

  • Haemoglobin analyser IVD, point-of-care
Hb meter, 100 Test Cartridges, 120 Capillary Transfer Tubes, 2 Optical Verifiers
Acon Laboratories, Inc.
C112-3061
In Commercial Distribution

  • 00682607000180 ()
  • 20682607611144 ()
  • 00682607611140 ()


  • Haemoglobin analyser IVD, point-of-care
Hb Meter, 50 Test Cartridges, 60 Capillary Transfer Tubes, 2 Optical Verifiers
Acon Laboratories, Inc.
C112-3051
In Commercial Distribution

  • 00682607000180 ()
  • 20682607611137 ()
  • 00682607611133 ()


  • Haemoglobin analyser IVD, point-of-care
Hb Meter, vial of 2 Optical Verifiers
Acon Laboratories, Inc.
C112-3041
In Commercial Distribution

  • 00682607000180 ()
  • 20682607611120 ()
  • 00682607611126 ()


  • Haemoglobin analyser IVD, point-of-care
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