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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BR Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995515
In Commercial Distribution

  • 00630414598420 ()
  • 00630414190846 ()
10995515

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995513
In Commercial Distribution

  • 00630414598406 ()
  • 00630414190839 ()
10995513

  • Multiple steroid hormone IVD, calibrator
Calibrator E Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995512
In Commercial Distribution

  • 00630414598390 ()
  • 00630414190822 ()
10995512

  • Multiple steroid hormone IVD, calibrator
Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995510
In Commercial Distribution

  • 00630414598376 ()
  • 00630414190815 ()
10995510

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator D - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995509
In Commercial Distribution

  • 00630414598369 ()
  • 00630414190808 ()
10995509

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995449
In Commercial Distribution

  • 00630414597799 ()
10995449

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV Total (HAVT) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995447
In Commercial Distribution

  • 00630414597775 ()
10995447

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995596
In Commercial Distribution

  • 00630414597768 ()
10995596

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
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
Urinary Total Protein (UPro) Calibrator Atellica CH - CAL 3 x 5.0mL
Siemens Healthcare Diagnostics Inc.
11099441
Not in Commercial Distribution

  • 00630414597621 ()
  • 00630414007168 ()
11099441

  • Total protein 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
TDM Calibrator Atellica CH - CAL 5 x 2 x 3.0mL
Siemens Healthcare Diagnostics Inc.
11099439
In Commercial Distribution

  • 00630414597607 ()
11099439

  • Multiple-therapy therapeutic drug monitoring 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
Microalbumin (µALB_2) Calibrator Atellica CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099435
In Commercial Distribution

  • 00630414597560 ()
11099435

  • Microalbumin IVD, calibrator
Liquid Specific Protein (LSP) Calibrator Atellica CH - CAL 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099434
In Commercial Distribution

  • 00630414597553 ()
11099434

  • Multiple-type clinical chemistry analyte profile 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
Fructosamine (Fruc) Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099432
In Commercial Distribution

  • 00630414597539 ()
  • 00630414007144 ()
11099432

  • Fructosamine IVD, calibrator
Cystatin-C (CysC) Calibrator Atellica™ CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099431
In Commercial Distribution

  • 00630414597522 ()
11099431

  • Cystatin C IVD, calibrator
C-Reative Protein (CRP) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099430
In Commercial Distribution

  • 00630414597515 ()
11099430

  • C-reactive protein (CRP) IVD, calibrator
High Sensitivity C-Reative Protein (hsCRP) Calibrator Atellica CH - CAS 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099412
In Commercial Distribution

  • 00630414597508 ()
11099412

  • C-reactive protein (CRP) 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
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
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
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
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