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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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
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
CH Wash Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099301
In Commercial Distribution

  • 00630414595733 ()
  • 00630414006901 ()
11099301

  • Wash/cleaning solution IVD, automated/semi-automated system
IMT Diluent Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099305
In Commercial Distribution

  • 00630414595726 ()
  • 00630414006932 ()
11099305

  • Buffered sample diluent IVD
IMT Standard B/Salt Bridge - Atellica CH - CONS 2 x 250mL/2 x 125mL
Siemens Healthcare Diagnostics Inc.
11099306
In Commercial Distribution

  • 00630414595719 ()
  • 00630414211497 ()
11099306

  • Multiple electrolyte IVD, calibrator
Water Bath Additive Fluid (WBA) Atellica CH - CONS 4 x 18mL
Siemens Healthcare Diagnostics Inc.
11099308
In Commercial Distribution

  • 00630414595702 ()
  • 00630414006987 ()
11099308

  • Wash/cleaning solution IVD, automated/semi-automated system
Reagent Probe Cleaner 4 Fluid (RPC4) Atellica CH - CONS 4 x 47mL
Siemens Healthcare Diagnostics Inc.
11099309
In Commercial Distribution

  • 00630414595696 ()
  • 00630414006994 ()
11099309

  • Wash/cleaning solution IVD, automated/semi-automated system
Lamp Coolant Fluid (LCA) Atellica CH - CONS 1 x 250mL
Siemens Healthcare Diagnostics Inc.
11099307
In Commercial Distribution

  • 00630414595689 ()
11099307

  • Wash/cleaning solution IVD, automated/semi-automated system
Calcium CPC( Ca) Atellica CH - RGT 3560T
Siemens Healthcare Diagnostics Inc.
11097595
In Commercial Distribution

  • 00630414595672 ()
11097595

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Complement C3 (C3) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097624
In Commercial Distribution

  • 00630414595665 ()
11097624

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
Complement C4 (C4) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097623
In Commercial Distribution

  • 00630414595658 ()
11097623

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
Pancreatic Amylase (Pamy) Atellica CH - RGT 1720T
Siemens Healthcare Diagnostics Inc.
11097622
Not in Commercial Distribution

  • 00630414595641 ()
11097622

  • Amylase isoenzyme IVD, kit, spectrophotometry
Glucose Oxidase (GluO) - Atellica CH - RGT - 5600T
Siemens Healthcare Diagnostics Inc.
11097621
In Commercial Distribution

  • 00630414595634 ()
  • 00630414007250 ()
11097621

  • Glucose IVD, kit, spectrophotometry
Immunoglobulin M ( IgM_2) Atellica CH - RGT 720T
Siemens Healthcare Diagnostics Inc.
11097620
In Commercial Distribution

  • 00630414595627 ()
11097620

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Immunoglobulin A (IgA_2) Atellica CH - RGT 600T
Siemens Healthcare Diagnostics Inc.
11097619
In Commercial Distribution

  • 00630414595610 ()
11097619

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Rheumatoid Factors (RF) - Atellica CH - RGT - 360T
Siemens Healthcare Diagnostics Inc.
11097618
In Commercial Distribution

  • 00630414595603 ()
11097618

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Magnesium (Mg) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097612
In Commercial Distribution

  • 00630414595597 ()
11097612

  • Magnesium (Mg2+) IVD, kit, spectrophotometry
Fructosamie (Fruc) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097637
In Commercial Distribution

  • 00630414595580 ()
11097637

  • Fructosamine IVD, kit, spectrophotometry
Cystatin C (CysC) Atellica™ CH - RGT 800T
Siemens Healthcare Diagnostics Inc.
11097636
Not in Commercial Distribution

  • 00630414595573 ()
11097636

  • Cystatin C IVD, kit, nephelometry/turbidimetry
IM Acid/Base Atellica IM - CONS 2x1x1.5L
Siemens Healthcare Diagnostics Inc.
11098500
In Commercial Distribution

  • 00630414595542 ()
11098500

  • Chemiluminescent immunoassay signal generation kit IVD
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