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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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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
HBsAgII (HBsII) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10492138
In Commercial Distribution

  • 00630414578170 ()
10492138

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
CA 19-9 bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10491974
In Commercial Distribution

  • 00630414577135 ()
10491974

  • Buffered sample diluent IVD
CA 19-9 Diluent (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10491972
In Commercial Distribution

  • 00630414577128 ()
  • 00630414005874 ()
10491972

  • Buffered sample diluent IVD
Enhanced Estradiol 2 Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10491878
In Commercial Distribution

  • 00630414575100 ()
  • 00630414005867 ()
10491878

  • Buffered sample diluent IVD
ADVIA 120 Hematology System
Siemens Healthcare Diagnostics Inc.
10360959
In Commercial Distribution

  • 00630414575025 ()
067-A004-14

  • Haematological cell analyser IVD
ADVIA 120 Hematology System
Siemens Healthcare Diagnostics Inc.
10360958
In Commercial Distribution

  • 00630414574868 ()
067-A004-13

  • Haematological cell analyser IVD
Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10491445
In Commercial Distribution

  • 00630414574646 ()
10491445

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
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
HbA1C Kit - ADVIA Chem. - CAL - 2x4x0,5mL
Siemens Healthcare Diagnostics Inc.
10491408
Not in Commercial Distribution

  • 00630414574516 ()
10491408

  • Glycated haemoglobin (HbA1c) IVD, calibrator
CA 19-9 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10491379
In Commercial Distribution

  • 00630414574257 ()
10491379

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 19-9 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10491244
In Commercial Distribution

  • 00630414574028 ()
10491244

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
ADVIA® CENTAUR® XP Instrument
Siemens Healthcare Diagnostics Inc.
10364455
In Commercial Distribution

  • 00630414573564 ()
078-A011-03

  • Chemiluminescent immunoassay analyser IVD
Estradiol - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10490889
In Commercial Distribution

  • 00630414573342 ()
10490889

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
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
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