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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CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995488
In Commercial Distribution

  • 00630414598154 ()
10995488

  • Cancer antigen 15-3 (CA15-3) IVD, control
CA 15-3 Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995485
In Commercial Distribution

  • 00630414598123 ()
10995485

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 125II Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995483
In Commercial Distribution

  • 00630414598109 ()
  • 00630414190648 ()
10995483

  • Cancer antigen 125 (CA125) IVD, calibrator
BR Pretreatment Atellica IM - CONS (2PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995480
In Commercial Distribution

  • 00630414598079 ()
  • 00630414007366 ()
10995480

  • Cancer antigen 27-29 (CA27-29) IVD, reagent
BR CA27-29 Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995479
In Commercial Distribution

  • 00630414598062 ()
10995479

  • Cancer antigen 27-29 (CA27-29) IVD, control
BR CA27-29 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995477
In Commercial Distribution

  • 00630414598048 ()
  • 00630414007359 ()
10995477

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
BNP QC Kit Atellica IM - CLT 3 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995475
In Commercial Distribution

  • 00630414598024 ()
10995475

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
BNP Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995474
In Commercial Distribution

  • 00630414598017 ()
10995474

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
BNP - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995472
In Commercial Distribution

  • 00630414597997 ()
  • 00630414007342 ()
10995472

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
TPO Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995470
In Commercial Distribution

  • 00630414597973 ()
10995470

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
TPO Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995469
In Commercial Distribution

  • 00630414597966 ()
10995469

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
TPOAb Ancillary Diluent - Atellica IM - CONS 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995468
In Commercial Distribution

  • 00630414597959 ()
  • 00630414007328 ()
10995468

  • Buffered sample diluent IVD
TG Ab - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995462
In Commercial Distribution

  • 00630414597898 ()
  • 00630414007298 ()
10995462

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
TG Ab - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995461
In Commercial Distribution

  • 00630414597881 ()
10995461

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995453
In Commercial Distribution

  • 00630414597836 ()
10995453

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
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 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
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
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
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
Fructosamine (Fruc) Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099432
In Commercial Distribution

  • 00630414597539 ()
  • 00630414007144 ()
11099432

  • Fructosamine 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
Atellica CH DRUG CAL II - CAL 5 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
11099405
In Commercial Distribution

  • 00630414597485 ()
  • 00630414211565 ()
11099405

  • Multiple-therapy therapeutic drug monitoring 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
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
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
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 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
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
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
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