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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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Stat Profile Prime Plus Reference Cartridge
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 00385480578233 ()
57823

  • Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile Prime Plus MicroSensor Card™ BUN, Creatinine
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480578216 ()
  • 00385480578219 ()
57821

  • Single-channel clinical chemistry analyser IVD, point-of-care
Calibrator Flush Fixture
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 00385480574587 ()
57458

  • Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile Prime Plus® Analyzer
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480574003 ()
  • 00385480574006 ()
57400

  • Single-channel clinical chemistry analyser IVD, point-of-care
No Description
ALTIMATE MEDICAL INC.
Bantam Extra Small
In Commercial Distribution

  • 10858921006079 ()


  • Manual stander
  • Pneumatic stander
  • Electric stander
No Description
ALTIMATE MEDICAL INC.
Bantam Small
In Commercial Distribution

  • 10858921006062 ()


  • Electric stander
  • Pneumatic stander
  • Manual stander
The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer.The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system.
Siemens Healthcare Diagnostics Inc.
11537761
In Commercial Distribution

  • 00630414607962 ()
11537761

  • Urine analyser IVD, point-of-care
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
10376323
In Commercial Distribution

  • 00630414578330 ()
10376323

  • Urine analyser IVD, point-of-care
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
10379675
In Commercial Distribution

  • 00630414574639 ()
10379675

  • Urine analyser IVD, point-of-care
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
10379677
In Commercial Distribution

  • 00630414572314 ()
10379677

  • Urine analyser IVD, point-of-care
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