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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HAV IgM Ab (aHAVM) QC Kit Atellica IM - CLT 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10995445
In Commercial Distribution

  • 00630414597744 ()
10995445

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995444
In Commercial Distribution

  • 00630414597737 ()
10995444

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alpha-Fetoprotein(AFP) - Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995443
In Commercial Distribution

  • 00630414597720 ()
10995443

  • Alpha-fetoprotein (AFP) IVD, control
RBC Folate - Atellica IM - CONS - 4 x 30mL
Siemens Healthcare Diagnostics Inc.
10995440
In Commercial Distribution

  • 00630414597690 ()
  • 00630414190600 ()
10995440

  • Dithiothriotol (DTT) reagent IVD
ß2-Microglobulin (B2M) Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099442
In Commercial Distribution

  • 00630414597638 ()
  • 00630414007175 ()
11099442

  • Beta-2-microglobulin IVD, calibrator
Toxicology (TOX) Calibrator Atellica CH - CAL 5 x 2 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099440
In Commercial Distribution

  • 00630414597614 ()
  • 00630414007090 ()
11099440

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Special Chemistry (SPCL) Calibrator Atellica CH - CAL 10 x 5.0mL
Siemens Healthcare Diagnostics Inc.
11099438
In Commercial Distribution

  • 00630414597591 ()
  • 00630414007151 ()
11099438

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Methadone Metabolite (MetMtb) Calibrator Atellica CH - CAL 1 x 10mL
Siemens Healthcare Diagnostics Inc.
11099437
Not in Commercial Distribution

  • 00630414597584 ()
11099437

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
Lipoprotein a (LP(a)) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099433
In Commercial Distribution

  • 00630414597546 ()
11099433

  • Lipoprotein A IVD, calibrator
Cystatin-C (CysC) Calibrator Atellica™ CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099431
Not in Commercial Distribution

  • 00630414597522 ()
11099431

  • Cystatin C IVD, calibrator
Chemistry Calibrator Atellica CH - CAL 12 x 3.0mL
Siemens Healthcare Diagnostics Inc.
11099411
In Commercial Distribution

  • 00630414597492 ()
  • 00630414007106 ()
11099411

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
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
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
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
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 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
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
ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD
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
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
Lactate Dehydrogenase (LDLP) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097594
In Commercial Distribution

  • 00630414596464 ()
11097594

  • Total lactate dehydrogenase (LDH) 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
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
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
Lipase (Lip) Atellica CH - RGT 1280T
Siemens Healthcare Diagnostics Inc.
11097606
In Commercial Distribution

  • 00630414596358 ()
11097606

  • Lipase 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
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
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
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-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
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
LDL Cholesterol Direct (D LDL) Atellica CH - RGT 1600T
Siemens Healthcare Diagnostics Inc.
11097632
Not in Commercial Distribution

  • 00630414596181 ()
11097632

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
High Sensitivity C-Reactive Protein (hsCRP) Atellica CH - RGT 740T
Siemens Healthcare Diagnostics Inc.
11097633
In Commercial Distribution

  • 00630414596174 ()
11097633

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Antistreptolysine O (ASO_2) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097634
In Commercial Distribution

  • 00630414596167 ()
11097634

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
IMT Diluent Check Fluid Atellica CH - CONS 6 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099325
In Commercial Distribution

  • 00630414596150 ()
  • 00630414007069 ()
11099325

  • Multiple electrolyte IVD, reagent
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