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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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
In Commercial Distribution

  • 00630414595573 ()
11097636

  • Cystatin C IVD, kit, nephelometry/turbidimetry
ß2-Microglobulin (B2M) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097635
In Commercial Distribution

  • 00630414595566 ()
11097635

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
Lipoprotein A (LP(a)) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097627
In Commercial Distribution

  • 00630414595559 ()
11097627

  • Lipoprotein A 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
Total Iron Binding Capacity ( TIBC) Atellica CH - RGT 800T
Siemens Healthcare Diagnostics Inc.
11097525
In Commercial Distribution

  • 00630414595535 ()
11097525

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
No Description
Siemens Healthcare Diagnostics Inc.
10718756
In Commercial Distribution

  • 00630414595504 ()
780666178

  • Buffered wash solution IVD
No Description
Siemens Healthcare Diagnostics Inc.
10718755
In Commercial Distribution

  • 00630414595498 ()
780666071

  • pH-adjusted buffer solution IVD
ISE BUFFER 2 - ADVIA Chem. - CONS - 1x3000mL
Siemens Healthcare Diagnostics Inc.
10718754
In Commercial Distribution

  • 00630414595481 ()
780665970

  • pH-adjusted buffer solution IVD
Cuvette Detergent - ADVIA Chem. - CONS - 4x500mL
Siemens Healthcare Diagnostics Inc.
10718753
In Commercial Distribution

  • 00630414595474 ()
  • 00630414006109 ()
780665872

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA® Chemistry XPT System
Siemens Healthcare Diagnostics Inc.
10723034
In Commercial Distribution

  • 00630414595467 ()
10723034

  • Multiple clinical chemistry analyser IVD, laboratory
Reagent tablets for the detection of Bilirubin in urine
Siemens Healthcare Diagnostics Inc.
10337316
In Commercial Distribution

  • 00630414595191 ()
A2591B24

  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
VERSACELL X3 Instrument
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10793839
In Commercial Distribution

  • 00630414595177 ()
10793839

  • Specimen processing instrument IVD
Creatinine Flex® reagent cartridge, 2160 Tests
Siemens Healthcare Diagnostics Inc.
10872082
In Commercial Distribution

  • 00630414595016 ()
  • 00630414006130 ()
K1033A

  • Creatinine IVD, kit, spectrophotometry
Creatinine Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10872079
In Commercial Distribution

  • 00630414595009 ()
  • 00630414006123 ()
DF33B

  • Creatinine IVD, kit, spectrophotometry
No Description
Siemens Healthcare Diagnostics Inc.
10718484
In Commercial Distribution

  • 00630414594972 ()
10718484

  • Phosphate buffer/Sorenson buffer solution IVD
No Description
Siemens Healthcare Diagnostics Inc.
10718483
In Commercial Distribution

  • 00630414594965 ()
10718483

  • Biological stain IVD
ADVID Autoslide May Grunwald Stain
Siemens Healthcare Diagnostics Inc.
10718482
In Commercial Distribution

  • 00630414594958 ()
10718482

  • Biological stain IVD
Phosphorus Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10720277
In Commercial Distribution

  • 00630414594484 ()
  • 00630414006116 ()
DF61A

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Dimension® EXL with LM integrated chemistry system and Sample Transfer Module
Siemens Healthcare Diagnostics Inc.
10639337
In Commercial Distribution

  • 00630414593593 ()
778031.911

  • Multiple clinical chemistry analyser IVD, laboratory
Dimension® EXL™ 200 Integrated Chemistry System
Siemens Healthcare Diagnostics Inc.
10636929
In Commercial Distribution

  • 00630414593579 ()
778041.911

  • Multiple clinical chemistry analyser IVD, laboratory
The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Siemens Healthcare Diagnostics Reagent Strips for Urinalysis, such as Multistix® 10 SG and Multistix PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine ratio, Specific Gravity, and Urobilinogen.
Siemens Healthcare Diagnostics Inc.
10636672
In Commercial Distribution

  • 00630414593562 ()
1420US

  • Urine analyser IVD, laboratory
Dimension Vista® 500 Intelligent Lab System
Siemens Healthcare Diagnostics Inc.
10488217
In Commercial Distribution

  • 00630414593517 ()
1000034648

  • Multiple clinical chemistry analyser IVD, laboratory
ADVIA® CENTAUR® CP Refurbished Instrument
Siemens Healthcare Diagnostics Inc.
10476243
In Commercial Distribution

  • 00630414593302 ()
086-A002R01

  • Chemiluminescent immunoassay analyser IVD
Vitamin D 25-OH - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10699533
In Commercial Distribution

  • 00630414592718 ()
10699533

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
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