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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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
HbA1c - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10485591
Not in Commercial Distribution

  • 00630414571270 ()
10485591

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized 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.
10376322
In Commercial Distribution

  • 00630414571263 ()
10376322

  • Multichannel clinical chemistry analyser IVD, laboratory
Ascorbic acid for red cell folic acid determinations with IMMULITE(R)
Siemens Healthcare Diagnostics Inc.
10485435
In Commercial Distribution

  • 00630414570587 ()
10485435

  • Folate (vitamin B9) IVD, reagent
NA+/K+/CA++/CL- Electrode fill solution. In vitro diagnostics material for use with RAPIDLab® 1200 electrodes.
Siemens Healthcare Diagnostics Inc.
10376882
In Commercial Distribution

  • 00630414570501 ()
  • 00630414010243 ()
10376882

  • Ion selective electrode (ISE) reference solution IVD, reagent
pH electrode fill soultion, in vitro diagnostics material for use with RAPIDLab® 1200 series electrodes
Siemens Healthcare Diagnostics Inc.
10376881
In Commercial Distribution

  • 00630414570495 ()
  • 00630414010236 ()
10376881

  • Hydrogen (H+)/pH electrode IVD
Ready Sensor™ Chloride Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10376880
In Commercial Distribution

  • 00630414570488 ()
  • 00630414010212 ()
10376880

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ Potassium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10376879
In Commercial Distribution

  • 00630414570471 ()
  • 00630414010205 ()
10376879

  • Potassium (K+) electrode IVD
Ready Sensor™ Sodium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10376878
In Commercial Distribution

  • 00630414570464 ()
  • 00630414010199 ()
10376878

  • Sodium (Na+) electrode IVD
Ready Sensor™ pH Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10376877
In Commercial Distribution

  • 00630414570457 ()
  • 00630414010175 ()
10376877

  • Blood pH electrode
Ecstasy - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378735
Not in Commercial Distribution

  • 00630414569857 ()
10378735

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
HbA1c - ADVIA Chem. - RGT - 2x80 tests
Siemens Healthcare Diagnostics Inc.
10379673
Not in Commercial Distribution

  • 00630414569512 ()
10379673

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Ethanol - ADVIA Chem. - RGT - 4x150 tests
Siemens Healthcare Diagnostics Inc.
10379635
In Commercial Distribution

  • 00630414569277 ()
10379635

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Cannabinoids - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378766
Not in Commercial Distribution

  • 00630414568829 ()
10378766

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Propoxyphene - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378765
Not in Commercial Distribution

  • 00630414568812 ()
10378765

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Phencyclidine - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378764
In Commercial Distribution

  • 00630414568805 ()
10378764

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Opiates - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378763
Not in Commercial Distribution

  • 00630414568799 ()
10378763

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Methadone - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378762
In Commercial Distribution

  • 00630414568782 ()
10378762

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Cocaine Metabolites - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378761
In Commercial Distribution

  • 00630414568775 ()
10378761

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Benzodiazepines - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378760
In Commercial Distribution

  • 00630414568768 ()
10378760

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Barbiturates - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378759
In Commercial Distribution

  • 00630414568751 ()
10378759

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Amphetamines - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378758
Not in Commercial Distribution

  • 00630414568744 ()
10378758

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
RAPIDPOINT® 340 Sampler Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 340 analyzer
Siemens Healthcare Diagnostics Inc.
10375808
In Commercial Distribution

  • 00630414568584 ()
10375808

  • Blood gas/haemoximetry analyser IVD, point-of-care
to be used on the RAPIDPOINT ® 340/350
Siemens Healthcare Diagnostics Inc.
10376971
In Commercial Distribution

  • 00630414566788 ()
10376971

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDPOINT® 350 Calcium Electrode, for use with RapidPoint® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10376547
In Commercial Distribution

  • 00630414566771 ()
10376547

  • Calcium (Ca2+) electrode IVD
RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10375812
In Commercial Distribution

  • 00630414566337 ()
10375812

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDPOINT® 350 Sampler Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10375810
In Commercial Distribution

  • 00630414566313 ()
10375810

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDPOINT® 340 Reagent Module, pH / pCO2 / pO2, for use with Rapidpoint 340 analyzers
Siemens Healthcare Diagnostics Inc.
10375807
In Commercial Distribution

  • 00630414566306 ()
10375807

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDPOINT® 350 Reagent Module pH / pCO2 / pO2 / Na+ / K+ / Cl- / Ca++ for use with Rapidpoint 350 analyzers
Siemens Healthcare Diagnostics Inc.
10375806
In Commercial Distribution

  • 00630414566290 ()
10375806

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Capillary Tube Kit, for use with RapidPoint® 340/350 analyzers; contents: 2 vials (100 each) capillary tubes, 1 bag (500) end caps
Siemens Healthcare Diagnostics Inc.
10375804
In Commercial Distribution

  • 00630414566283 ()
10375804

  • Capillary blood collection tube IVD, lithium heparin
RAPIDPOINT® 350 Chloride Electrode for use with Rapidpoint® 350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375802
In Commercial Distribution

  • 00630414566276 ()
10375802

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)
RAPIDPOINT® 340/350 pO2 Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375798
In Commercial Distribution

  • 00630414566269 ()
10375798

  • Blood oxygen electrode IVD
RAPIDPOINT® 340/350 PCO2 Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375797
In Commercial Distribution

  • 00630414566252 ()
10375797

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375796
In Commercial Distribution

  • 00630414566245 ()
10375796

  • Blood pH electrode
RAPIDPOINT® 340 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 340 analyzer
Siemens Healthcare Diagnostics Inc.
10375809
In Commercial Distribution

  • 00630414566238 ()
10375809

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Trouble shooting kit for use with RAPIDPoint® 350 blood gas analyzers
Siemens Healthcare Diagnostics Inc.
10375803
In Commercial Distribution

  • 00630414566221 ()
10375803

  • Blood gas/haemoximetry analyser IVD, point-of-care
TSH3-UL Master Curve Material Set - CENTAUR - CAL
Siemens Healthcare Diagnostics Inc.
10285735
In Commercial Distribution

  • 00630414565668 ()
4782400

  • Thyroid stimulating hormone (TSH) IVD, control
TBD
Siemens Healthcare Diagnostics Inc.
10361793
In Commercial Distribution

  • 00630414565583 ()
067-A020-03

  • Haematological cell analyser IVD
ADVIA Centaur® TSH3-UL (25-pack)
Siemens Healthcare Diagnostics Inc.
10361944
In Commercial Distribution

  • 00630414563268 ()
  • 00630414010564 ()
4862625

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Iron - ADVIA Chem. - RGT - 6x350 tests
Siemens Healthcare Diagnostics Inc.
10377510
In Commercial Distribution

  • 00630414561974 ()
10377510

  • Iron IVD, kit, spectrophotometry
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