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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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
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