SEARCH RESULTS FOR: siemens(7279 results)

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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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ADVIA Centaur® eE2 - 00630414574646

Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10491445
In Commercial Distribution

  • 00630414574646 ()
10491445

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

ADVIA® Chemistry Hemoglobin A1c_3 Calibrators - 00630414574516

HbA1C Kit - ADVIA Chem. - CAL - 2x4x0,5mL
Siemens Healthcare Diagnostics Inc.
10491408
Not in Commercial Distribution

  • 00630414574516 ()
10491408

  • Glycated haemoglobin (HbA1c) IVD, calibrator

ADVIA Centaur® CA 19-9™ - 00630414574028

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® eE2 - 00630414573342

Estradiol - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10490889
In Commercial Distribution

  • 00630414573342 ()
10490889

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

ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents - 00630414571270

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

  • 00630414571270 ()
10485591

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

CLINITEK Status® Connector - 00630414571263

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

RAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode Fill - 00630414570501

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

Ready Sensor™ GOLD Potassium Sensor - 00630414570471

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™ GOLD Sodium Sensor - 00630414570464

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™ GOLD pH Sensor - 00630414570457

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

ADVIA® Chemistry XTC Ecstasy Reagents - 00630414569857

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)

ADVIA® Chemistry THC_2 Cannabinoid_2 Reagents - 00630414568829

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)

ADVIA® Chemistry PCP_2 Phencyclidine_2 Reagents - 00630414568805

Phencyclidine - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378764
In Commercial Distribution

  • 00630414568805 ()
10378764

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry MDN_2 Methadone_2 Reagents - 00630414568782

Methadone - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378762
In Commercial Distribution

  • 00630414568782 ()
10378762

  • Methadone IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents - 00630414568768

Benzodiazepines - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378760
In Commercial Distribution

  • 00630414568768 ()
10378760

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry AMPH_2 Amphetamines_2 Reagents - 00630414568744

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® 340/350 Valve Module - 00630414566788

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 Ca++ Electrode - 00630414566771

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 Sampler Module - 00630414566313

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® 350 Reagent Module - 00630414566290

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)

RAPIDPOINT® 350 Cl- Electrode - 00630414566276

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 pCO2 Electrode - 00630414566252

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 - 00630414566245

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 - 00630414566238

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)

RAPIDPoint® 350 Trouble shooting kit - 00630414566221

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

ADVIA Centaur® TSH3-UL MCM - 00630414565668

TSH3-UL Master Curve Material Set - CENTAUR - CAL
Siemens Healthcare Diagnostics Inc.
10285735
In Commercial Distribution

  • 00630414565668 ()
4782400

  • Thyroid stimulating hormone (TSH) IVD, control

ADVIA(R) 2120i Hematology System - 00630414565583

TBD
Siemens Healthcare Diagnostics Inc.
10361793
In Commercial Distribution

  • 00630414565583 ()
067-A020-03

  • Haematological cell analyser IVD

ADVIA Centaur® TSH3-UL - 00630414563268

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

ADVIA® Chemistry VANC_2 Vancomycin_2 Reagents - 00630414561967

Vancomycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377509
Not in Commercial Distribution

  • 00630414561967 ()
10377509

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents - 00630414561943

Gentamicin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377507
In Commercial Distribution

  • 00630414561943 ()
10377507

  • Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry THEO_2 Theophylline_2 Reagents - 00630414561905

Theophyline - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377503
Not in Commercial Distribution

  • 00630414561905 ()
10377503

  • Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA Centaur® aHBs2 - 00630414561790

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10286268
In Commercial Distribution

  • 00630414561790 ()
4670661

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry CYSC Cystatin-C Calibrators - 00630414561578

Cystatin C - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10376487
Not in Commercial Distribution

  • 00630414561578 ()
10376487

  • Cystatin C IVD, calibrator

ADVIA® Chemistry Drug Calibrator I - 00630414561325

Drug 1 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376770
In Commercial Distribution

  • 00630414561325 ()
10376770

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA® Chemistry CARB_2 Reagents - 00630414560793

Carbamazepine - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376342
Not in Commercial Distribution

  • 00630414560793 ()
10376342

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® 2120i Hematology System - 00630414560045

ADVIA®2120i Hematology System
Siemens Healthcare Diagnostics Inc.
10285573
In Commercial Distribution

  • 00630414560045 ()
067-A013-01

  • Haematological cell analyser IVD

ADVIA Centaur® T3 MCM - 00630414559704

T3 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10361928
In Commercial Distribution

  • 00630414559704 ()
4848169

  • Total triiodothyronine (TT3) IVD, control

ADVIA ® 120/2120/2120i EZ WASH - 00630414558400

ADVIA®120/2120/2120i EZ WASH
Siemens Healthcare Diagnostics Inc.
10285021
In Commercial Distribution

  • 00630414558400 ()
4871500

  • Wash/cleaning solution IVD, automated/semi-automated system

ADVIA® Chemistry LP(A) CALIBRATOR - 00630414558257

LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator

ADVIA® Chemistry FRUC Calibrator - 00630414558240

Fructosamine - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285684
Not in Commercial Distribution

  • 00630414558240 ()
  • 00630414002996 ()
4865217

  • Fructosamine IVD, calibrator
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