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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HDL/LDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099402
Not in Commercial Distribution

  • 00630414597454 ()
  • 00630414007137 ()
11099402

  • Multiple lipid analyte IVD, calibrator
CO2 Calibrator Atellica CH - CAL 2 x 21.0mL
Siemens Healthcare Diagnostics Inc.
11099401
In Commercial Distribution

  • 00630414597447 ()
  • 00630414007113 ()
11099401

  • Carbon dioxide (CO2) IVD, calibrator
Drug Calibrator Atellica CH - CAL 5 x 2 x 3.0mL
Siemens Healthcare Diagnostics Inc.
11099336
In Commercial Distribution

  • 00630414597386 ()
  • 00630414211558 ()
11099336

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Chemistry III Calibrator Atellica CH - CAL 3 x 2 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099335
In Commercial Distribution

  • 00630414597379 ()
  • 00630414211541 ()
11099335

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Apolipoprotein A1 & B Calibrators Atellica CH - CAL 5 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099329
In Commercial Distribution

  • 00630414597317 ()
  • 00630414007120 ()
11099329

  • Multiple apolipoprotein IVD, calibrator
Hemoglobin A1c (A1c_3) Calibrator Atellica CH - CAL 4 x 2 x 0.5mL
Siemens Healthcare Diagnostics Inc.
11099328
Not in Commercial Distribution

  • 00630414597300 ()
  • 00630414211534 ()
11099328

  • Glycated haemoglobin (HbA1c) IVD, calibrator
Enzyme 3 (ENZ 3) Calibrator Atellica CH - CAL 6 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099319
In Commercial Distribution

  • 00630414597249 ()
  • 00630414007021 ()
11099319

  • Total creatine kinase (CK) IVD, calibrator
Enzyme 2 (ENZ 2) Calibrator Atellica CH - CAL 6 x 1.5mL
Siemens Healthcare Diagnostics Inc.
11099318
In Commercial Distribution

  • 00630414597232 ()
  • 00630414007038 ()
11099318

  • Multiple clinical chemistry enzyme IVD, calibrator
Enzyme 1 (ENZ 1) Calibrator Atellica CH - CAL 6 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099317
In Commercial Distribution

  • 00630414597225 ()
  • 00630414007014 ()
11099317

  • Multiple clinical chemistry enzyme IVD, calibrator
Alkaline Phosphatase Calibrator (ALP) Atellica CH - CAL 6 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099316
In Commercial Distribution

  • 00630414597218 ()
  • 00630414007045 ()
11099316

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Albumin BCP (AlbP) Calibrator Atellica CH - CAL 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099310
In Commercial Distribution

  • 00630414597201 ()
  • 00630414007052 ()
11099310

  • Albumin IVD, calibrator
IMMULITE(R) 2000 TSI Assay
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10876421
In Commercial Distribution

  • 00630414597188 ()
L2KSI2(D)

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD
APTIO INPUT/OUTPUT MODULE W/O SLOT
Siemens Healthcare Diagnostics Inc.
10713760
In Commercial Distribution

  • 00630414596754 ()
APT-201-01

  • Specimen processing instrument IVD
The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
Siemens Healthcare Diagnostics Products GmbH
10805311
In Commercial Distribution

  • 00630414596563 ()
10805311

  • Microscope slide stainer 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
A-LYTE™ IMT (Na K Cl) Atellica CH - RGT
Siemens Healthcare Diagnostics Inc.
11099315
In Commercial Distribution

  • 00630414596518 ()
  • 00630414006833 ()
11099315

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
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
Lactate Dehydrogenase (LDLP) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097594
In Commercial Distribution

  • 00630414596464 ()
11097594

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Creatinine Jaffe (Crea_2) Atellica CH - RGT 5888T
Siemens Healthcare Diagnostics Inc.
11097596
In Commercial Distribution

  • 00630414596457 ()
11097596

  • Creatinine IVD, kit, spectrophotometry
G-Glutamyltransferase (GGT) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097597
In Commercial Distribution

  • 00630414596440 ()
11097597

  • Gamma-glutamyltransferase (GGT) IVD, kit, 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
Amylase (Amy) Atellica CH - RGT 1050T
Siemens Healthcare Diagnostics Inc.
11097603
Not in Commercial Distribution

  • 00630414596389 ()
11097603

  • Total amylase IVD, kit, spectrophotometry
Total Protein (TP) - Atellica™ CH - RGT - 7400T
Siemens Healthcare Diagnostics Inc.
11097604
In Commercial Distribution

  • 00630414596372 ()
11097604

  • Total protein IVD, kit, spectrophotometry
Alanine Aminotransferase (ALT) Atellica CH - RGT 2550T
Siemens Healthcare Diagnostics Inc.
11097605
In Commercial Distribution

  • 00630414596365 ()
11097605

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
Lipase (Lip) Atellica CH - RGT 1280T
Siemens Healthcare Diagnostics Inc.
11097606
In Commercial Distribution

  • 00630414596358 ()
11097606

  • Lipase IVD, kit, spectrophotometry
Aspartate Aminotransferase (AST) Atellica CH - RGT 2550T
Siemens Healthcare Diagnostics Inc.
11097607
In Commercial Distribution

  • 00630414596341 ()
11097607

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Uric Acid (UA) Atellica CH - RGT 4800T
Siemens Healthcare Diagnostics Inc.
11097608
In Commercial Distribution

  • 00630414596334 ()
11097608

  • Uric acid IVD, kit, spectrophotometry
Cholesterol (Chol-2) Atellica CH - RGT 8400T
Siemens Healthcare Diagnostics Inc.
11097609
In Commercial Distribution

  • 00630414596327 ()
  • 00630414007229 ()
11097609

  • Total cholesterol lipid IVD, kit, spectrophotometry
Microalbumin (µALB_2) Atellica CH - RGT 840T
Siemens Healthcare Diagnostics Inc.
11097610
In Commercial Distribution

  • 00630414596310 ()
11097610

  • Microalbumin IVD, kit, nephelometry/turbidimetry
Phosphorus (IP) Atellica CH - RGT 5100T
Siemens Healthcare Diagnostics Inc.
11097611
In Commercial Distribution

  • 00630414596303 ()
11097611

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Transferrin (Tnf) - Atellica CH - RGT - 880T
Siemens Healthcare Diagnostics Inc.
11097613
In Commercial Distribution

  • 00630414596297 ()
11097613

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
Lactate (Lac) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11097614
Not in Commercial Distribution

  • 00630414596280 ()
11097614

  • Lactate IVD, kit, spectrophotometry
Cholinestrase (CHE) Atellica CH - RGT 270T
Siemens Healthcare Diagnostics Inc.
11097615
Not in Commercial Distribution

  • 00630414596273 ()
11097615

  • Acetylcholinesterase IVD, kit, spectrophotometry
Immunoglobulin G (IgG_2) Atellica CH - RGT 720T
Siemens Healthcare Diagnostics Inc.
11097616
In Commercial Distribution

  • 00630414596266 ()
11097616

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Prealbumin (PreAlb) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097617
In Commercial Distribution

  • 00630414596259 ()
11097617

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
Apolipoprotein A-1 (APO A1) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11097625
In Commercial Distribution

  • 00630414596242 ()
11097625

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Apolipoprotein B (APO B) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11097626
In Commercial Distribution

  • 00630414596235 ()
11097626

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Alpha-1-Acid-Antitrypsin (AAT) Atellica CH RGT 360T
Siemens Healthcare Diagnostics Inc.
11097628
In Commercial Distribution

  • 00630414596228 ()
11097628

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry
Alpha-1-AcidGlycoprotein (AAG) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097629
In Commercial Distribution

  • 00630414596211 ()
11097629

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Direct HDL Cholesterol (D-HDL) Atellica™ CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097630
Not in Commercial Distribution

  • 00630414596204 ()
11097630

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
C-Reactive Protein_2 (CRP_2) Atellica CH - RGT 1000T
Siemens Healthcare Diagnostics Inc.
11097631
In Commercial Distribution

  • 00630414596198 ()
11097631

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
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