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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IM Acid/Base Atellica IM - CONS 2x1x1.5L
Siemens Healthcare Diagnostics Inc.
11098500
In Commercial Distribution

  • 00630414595542 ()
11098500

  • Chemiluminescent immunoassay signal generation kit IVD
Total Iron Binding Capacity ( TIBC) Atellica CH - RGT 800T
Siemens Healthcare Diagnostics Inc.
11097525
In Commercial Distribution

  • 00630414595535 ()
11097525

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
No Description
Siemens Healthcare Diagnostics Inc.
10718756
In Commercial Distribution

  • 00630414595504 ()
780666178

  • Buffered wash solution IVD
No Description
Siemens Healthcare Diagnostics Inc.
10718755
In Commercial Distribution

  • 00630414595498 ()
780666071

  • pH-adjusted buffer solution IVD
ISE BUFFER 2 - ADVIA Chem. - CONS - 1x3000mL
Siemens Healthcare Diagnostics Inc.
10718754
In Commercial Distribution

  • 00630414595481 ()
780665970

  • pH-adjusted buffer solution IVD
Cuvette Detergent - ADVIA Chem. - CONS - 4x500mL
Siemens Healthcare Diagnostics Inc.
10718753
In Commercial Distribution

  • 00630414595474 ()
  • 00630414006109 ()
780665872

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA® Chemistry XPT System
Siemens Healthcare Diagnostics Inc.
10723034
In Commercial Distribution

  • 00630414595467 ()
10723034

  • Multiple clinical chemistry analyser IVD, laboratory
Reagent tablets for the detection of Bilirubin in urine
Siemens Healthcare Diagnostics Inc.
10337316
In Commercial Distribution

  • 00630414595191 ()
A2591B24

  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
VERSACELL X3 Instrument
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10793839
In Commercial Distribution

  • 00630414595177 ()
10793839

  • Specimen processing instrument IVD
Creatinine Flex® reagent cartridge, 2160 Tests
Siemens Healthcare Diagnostics Inc.
10872082
In Commercial Distribution

  • 00630414595016 ()
  • 00630414006130 ()
K1033A

  • Creatinine IVD, kit, spectrophotometry
Creatinine Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10872079
In Commercial Distribution

  • 00630414595009 ()
  • 00630414006123 ()
DF33B

  • Creatinine IVD, kit, spectrophotometry
No Description
Siemens Healthcare Diagnostics Inc.
10718484
In Commercial Distribution

  • 00630414594972 ()
10718484

  • Phosphate buffer/Sorenson buffer solution IVD
No Description
Siemens Healthcare Diagnostics Inc.
10718483
In Commercial Distribution

  • 00630414594965 ()
10718483

  • Biological stain IVD
ADVID Autoslide May Grunwald Stain
Siemens Healthcare Diagnostics Inc.
10718482
In Commercial Distribution

  • 00630414594958 ()
10718482

  • Biological stain IVD
Phosphorus Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10720277
In Commercial Distribution

  • 00630414594484 ()
  • 00630414006116 ()
DF61A

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Dimension® EXL with LM integrated chemistry system and Sample Transfer Module
Siemens Healthcare Diagnostics Inc.
10639337
In Commercial Distribution

  • 00630414593593 ()
778031.911

  • Multiple clinical chemistry analyser IVD, laboratory
Dimension® EXL™ 200 Integrated Chemistry System
Siemens Healthcare Diagnostics Inc.
10636929
In Commercial Distribution

  • 00630414593579 ()
778041.911

  • Multiple clinical chemistry analyser IVD, laboratory
The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Siemens Healthcare Diagnostics Reagent Strips for Urinalysis, such as Multistix® 10 SG and Multistix PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine ratio, Specific Gravity, and Urobilinogen.
Siemens Healthcare Diagnostics Inc.
10636672
In Commercial Distribution

  • 00630414593562 ()
1420US

  • Urine analyser IVD, laboratory
Dimension Vista® 500 Intelligent Lab System
Siemens Healthcare Diagnostics Inc.
10488217
In Commercial Distribution

  • 00630414593517 ()
1000034648

  • Multiple clinical chemistry analyser IVD, laboratory
ADVIA® CENTAUR® CP Refurbished Instrument
Siemens Healthcare Diagnostics Inc.
10476243
In Commercial Distribution

  • 00630414593302 ()
086-A002R01

  • Chemiluminescent immunoassay analyser IVD
Vitamin D 25-OH - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10699533
In Commercial Distribution

  • 00630414592718 ()
10699533

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® VITAMIN D TOTAL (VITD) ASSAY
Siemens Healthcare Diagnostics Inc.
10699201
In Commercial Distribution

  • 00630414592503 ()
10699201

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® Systems QC VitD
Siemens Healthcare Diagnostics Inc.
10699200
In Commercial Distribution

  • 00630414592497 ()
10699200

  • Multiple form 25-hydroxy Vitamin D IVD, control
Intact parathyroid hormone (Quality Control iPTH QC) Set - 3x2x1mL - REF
Siemens Healthcare Diagnostics Inc.
10699161
In Commercial Distribution

  • 00630414592404 ()
10699161

  • Parathyroid hormone (PTH) IVD, control
Intact parathyroid hormone (iPTH) - 500 tests - 5PK -REF2
Siemens Healthcare Diagnostics Inc.
10699160
In Commercial Distribution

  • 00630414592398 ()
  • 00630414017242 ()
10699160

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Intact Parathyroid Hormone (PTH) - ADVIA Centaur® - RGT (REF) – 500T
Siemens Healthcare Diagnostics Inc.
10699159
In Commercial Distribution

  • 00630414592381 ()
10699159

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Intact parathyroid hormone Quality Control iPTH QC) Set - 3x2x1mL
Siemens Healthcare Diagnostics Inc.
10699156
In Commercial Distribution

  • 00630414592350 ()
10699156

  • Parathyroid hormone (PTH) IVD, control
Intact Parathyroid Hormone (PTH) - ADVIA Centaur® - RGT – 500T
Siemens Healthcare Diagnostics Inc.
10699155
In Commercial Distribution

  • 00630414592343 ()
  • 00630414017242 ()
10699155

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Intact Parathyroid Hormone (PTH) - ADVIA Centaur® - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10699154
In Commercial Distribution

  • 00630414592336 ()
10699154

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
aCCP Control Set - CENTAUR - - CENTAUR - CTL - 1x2x7mL
Siemens Healthcare Diagnostics Inc.
10699150
In Commercial Distribution

  • 00630414592329 ()
10699150

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
CCP IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10699141
In Commercial Distribution

  • 00630414592312 ()
10699141

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
Anti-CCP IgG (aCCP) MCM
Siemens Healthcare Diagnostics Inc.
10699140
In Commercial Distribution

  • 00630414592305 ()
10699140

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10698706
In Commercial Distribution

  • 00630414591407 ()
10698706

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Hepatitis B e Antigen (HBeAg) Assay Kit (1-pack) 50T
Siemens Healthcare Diagnostics Inc.
10698639
In Commercial Distribution

  • 00630414591315 ()
10698639

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Intact parathyroid hormone Master Curve Material (iPTH MCM) Set - 7x1 mL - 7 Levels.
Siemens Healthcare Diagnostics Inc.
10698597
In Commercial Distribution

  • 00630414591278 ()
10698597

  • Parathyroid hormone (PTH) IVD, control
Testosterone II (TSTII) - ADVIA Centaur® - RGT (REF) – 500T
Siemens Healthcare Diagnostics Inc.
10696864
In Commercial Distribution

  • 00630414591155 ()
10696864

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Testosterone II - RGT - CENTAUR - 500 tests
Siemens Healthcare Diagnostics Inc.
10696863
In Commercial Distribution

  • 00630414591148 ()
10696863

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Testosterone II - RGT -100 Tests
Siemens Healthcare Diagnostics Inc.
10696862
In Commercial Distribution

  • 00630414591131 ()
10696862

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10697757
In Commercial Distribution

  • 00630414591056 ()
10697757

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® Calibrator 30 (2-pack)
Siemens Healthcare Diagnostics Inc.
10697756
In Commercial Distribution

  • 00630414591049 ()
10697756

  • Multiple steroid hormone IVD, calibrator
Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator
Rinse additive for CLINITEK Novus® automated urine chemistry system.
Siemens Healthcare Diagnostics Inc.
10697754
In Commercial Distribution

  • 00630414590936 ()
  • 00630414010007 ()
10697754

  • Buffered wash solution IVD
Triglyceride - ADVIA Chem. - Conc. RGT - 4x1063/4x971 tests
Siemens Healthcare Diagnostics Inc.
10697575
In Commercial Distribution

  • 00630414590394 ()
  • 00630414005966 ()
10697575

  • Triglyceride IVD, kit, spectrophotometry
ADVIA Centaur® CHIV Quality Control Material
Siemens Healthcare Diagnostics Inc.
10697214
In Commercial Distribution

  • 00630414590202 ()
10697214

  • HIV1/HIV2 antigen/antibody IVD, control
Ferritin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10361938
In Commercial Distribution

  • 00630414590189 ()
4862277

  • Ferritin IVD, kit, nephelometry/turbidimetry
b2 Microglobulin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361937
Not in Commercial Distribution

  • 00630414590165 ()
4862161

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
a1 Acid Glycoprotein - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361936
Not in Commercial Distribution

  • 00630414590158 ()
4862129

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
RAPIDPoint® 500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491449
In Commercial Distribution

  • 00630414589770 ()
10491449

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 500 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491448
In Commercial Distribution

  • 00630414589763 ()
10491448

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 500 Measurement Cartridge (250 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491447
In Commercial Distribution

  • 00630414589756 ()
10491447

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
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