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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APTIO INPUT/OUTPUT MODULE W/O SLOT
Siemens Healthcare Diagnostics Inc.
10713760
In Commercial Distribution

  • 00630414596754 ()
APT-201-01

  • Specimen processing instrument IVD
Check ReagentT Fluid (CHK) Atellica CH - CONS 4 X 47mL/4 X 47mL
Siemens Healthcare Diagnostics Inc.
11099311
In Commercial Distribution

  • 00630414596556 ()
  • 00630414211503 ()
11099311

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
Reagent Probe Cleaner 1 (RPC1) Atellica CH - CONS 4 X 44.6mL/4 X 44.6mL
Siemens Healthcare Diagnostics Inc.
11099312
In Commercial Distribution

  • 00630414596549 ()
  • 00630414211510 ()
11099312

  • Wash/cleaning solution IVD, automated/semi-automated system
Reagent Probe Cleaner 2 (RPC2) Atellica CH - CONS 4 X 44.6mL/4 X 44.6mL
Siemens Healthcare Diagnostics Inc.
11099313
In Commercial Distribution

  • 00630414596532 ()
  • 00630414211527 ()
11099313

  • Wash/cleaning solution IVD, automated/semi-automated system
Albumin BCG (Alb) Atellica CH - RGT 6800T
Siemens Healthcare Diagnostics Inc.
11097590
In Commercial Distribution

  • 00630414596501 ()
  • 00630414007182 ()
11097590

  • Albumin IVD, kit, nephelometry/turbidimetry
Triglycerides (Trig) Atellica CH - RGT 2000T
Siemens Healthcare Diagnostics Inc.
11097591
Not in Commercial Distribution

  • 00630414596495 ()
  • 00630414007199 ()
11097591

  • Triglyceride IVD, kit, spectrophotometry
Glucose Hexokinase ( GluH_3) Atellica CH - RGT 6240T
Siemens Healthcare Diagnostics Inc.
11097592
In Commercial Distribution

  • 00630414596488 ()
11097592

  • Glucose IVD, kit, spectrophotometry
Urea Nitrogen (UN_c) Atellica CH - RGT 6240T
Siemens Healthcare Diagnostics Inc.
11097593
In Commercial Distribution

  • 00630414596471 ()
11097593

  • Urea IVD, kit, enzyme spectrophotometry
Alanine Aminotransferase P5P (ALTP5P) Atellica CH - RGT 1684T
Siemens Healthcare Diagnostics Inc.
11097598
In Commercial Distribution

  • 00630414596433 ()
11097598

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
Aspartate Aminotransferase P5P (ASTP5P) - Atellica™ CH - RGT - 1684T
Siemens Healthcare Diagnostics Inc.
11097599
In Commercial Distribution

  • 00630414596426 ()
11097599

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Alkaline Phosphatase, Concentrated (ALP_2c) Atellica CH - Rgt 4800T
Siemens Healthcare Diagnostics Inc.
11097600
In Commercial Distribution

  • 00630414596419 ()
11097600

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Iron (Iron_2) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097601
In Commercial Distribution

  • 00630414596402 ()
11097601

  • Iron IVD, kit, spectrophotometry
Digoxin (Dgn) Atellica CH - RGT 1600T
Siemens Healthcare Diagnostics Inc.
11097526
In Commercial Distribution

  • 00630414595863 ()
11097526

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Atellica CH Methadone Metabolite (EDDP) (MetMtb)
Siemens Healthcare Diagnostics Inc.
11097527
Not in Commercial Distribution

  • 00630414595856 ()
11097527

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
TD TRICYC ANTIDEPRESSANT ASSAY, TCA
Siemens Healthcare Diagnostics Inc.
11097528
In Commercial Distribution

  • 00630414595849 ()
11097528

  • Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)
Ammonia (Amm) Atellica CH – RGT 480T
Siemens Healthcare Diagnostics Inc.
11097529
In Commercial Distribution

  • 00630414595832 ()
  • 00630414006888 ()
11097529

  • Ammonia IVD, kit, spectrophotometry
Albumin BCP (AlbP) Atellica CH - RGT 6400T
Siemens Healthcare Diagnostics Inc.
11097530
In Commercial Distribution

  • 00630414595825 ()
  • 00630414006871 ()
11097530

  • Albumin IVD, kit, spectrophotometry
Total Bilirubin (Tbil_2) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097531
In Commercial Distribution

  • 00630414595818 ()
11097531

  • Total bilirubin IVD, kit, spectrophotometry
Direct Bilirubin (Dbil_2) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097532
In Commercial Distribution

  • 00630414595801 ()
11097532

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Enzymatic Creatinine ( Ecrea_2) Atellica CH - RGT 1400T
Siemens Healthcare Diagnostics Inc.
11097533
In Commercial Distribution

  • 00630414595795 ()
11097533

  • Creatinine IVD, kit, spectrophotometry
EMPTY PACK Atellica CH - CONS
Siemens Healthcare Diagnostics Inc.
11097534
In Commercial Distribution

  • 00630414595788 ()
  • 00630414225777 ()
11097534

  • General laboratory assay tray
CH Diluent Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099300
In Commercial Distribution

  • 00630414595771 ()
  • 00630414006925 ()
11099300

  • Buffered sample diluent IVD
CH Conditioner Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099302
In Commercial Distribution

  • 00630414595764 ()
  • 00630414006970 ()
11099302

  • Wash/cleaning solution IVD, automated/semi-automated system
CH Cleaner Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099303
In Commercial Distribution

  • 00630414595757 ()
  • 00630414006963 ()
11099303

  • Wash/cleaning solution IVD, automated/semi-automated system
IMT Standard A - Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099304
In Commercial Distribution

  • 00630414595740 ()
  • 00630414006949 ()
11099304

  • Multiple electrolyte IVD, calibrator
Test tube, non-sterile
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10374179
In Commercial Distribution

  • 00630414982410 ()
905289

  • General specimen container IVD, no additive/medium
Test tube, non-sterile
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10374178
In Commercial Distribution

  • 00630414982403 ()
905288

  • General specimen container IVD, no additive/medium
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10697937
In Commercial Distribution

  • 00630414981147 ()
10697937

  • Urine analyser IVD, laboratory
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10494134
In Commercial Distribution

  • 00630414981130 ()
10494134

  • Urine analyser IVD, laboratory
LOCI Anemia Calibrator, 2 X 5 X 1.0 mL
Siemens Healthcare Diagnostics Inc.
10463372
In Commercial Distribution

  • 00630414976631 ()
RC640

  • Multiple anaemia-related analyte IVD, calibrator
LOCI Vitamin B12 Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10463371
In Commercial Distribution

  • 00630414976624 ()
  • 00630414005508 ()
RF642

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
LOCI Folate Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10463370
In Commercial Distribution

  • 00630414976617 ()
  • 00630414005492 ()
RF644

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380037
In Commercial Distribution

  • 00630414974187 ()
LSCP

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385210
In Commercial Distribution

  • 00630414973159 ()
L2ZT

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385211
In Commercial Distribution

  • 00630414972923 ()
L2ZC

  • General specimen container IVD, no additive/medium
The Stratus® CS Acute Care(TM) D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10701511
In Commercial Distribution

  • 00630414986166 ()
  • 00630414010014 ()
CDDMRE

  • D-dimer IVD, kit, fluorescent immunoassay
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385183
In Commercial Distribution

  • 00630414974194 ()
LSCC

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385205
In Commercial Distribution

  • 00630414974064 ()
LSMC

  • General specimen container IVD, no additive/medium
Microsampling Tubes - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385207
In Commercial Distribution

  • 00630414973937 ()
LMST

  • General specimen container IVD, no additive/medium
Allergen Tube Septa
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10282849
In Commercial Distribution

  • 00630414965741 ()
L2ATS2

  • General specimen container IVD, no additive/medium
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