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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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Atellica CH IgM_2 - 00630414595627

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

Atellica CH IgA_2 - 00630414595610

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

Atellica CH RF - 00630414595603

Rheumatoid Factors (RF) - Atellica CH - RGT - 360T
Siemens Healthcare Diagnostics Inc.
11097618
In Commercial Distribution

  • 00630414595603 ()
11097618

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Atellica CH Fruc - 00630414595580

Fructosamie (Fruc) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097637
In Commercial Distribution

  • 00630414595580 ()
11097637

  • Fructosamine IVD, kit, spectrophotometry

Atellica™ CH CysC - 00630414595573

Cystatin C (CysC) Atellica™ CH - RGT 800T
Siemens Healthcare Diagnostics Inc.
11097636
In Commercial Distribution

  • 00630414595573 ()
11097636

  • Cystatin C IVD, kit, nephelometry/turbidimetry

Atellica CH B2M - 00630414595566

ß2-Microglobulin (B2M) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097635
In Commercial Distribution

  • 00630414595566 ()
11097635

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Atellica CH Lp(a) - 00630414595559

Lipoprotein A (LP(a)) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097627
In Commercial Distribution

  • 00630414595559 ()
11097627

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

Dimension Vista® Flex® reagent cartridge CRE2 - 00630414595016

Creatinine Flex® reagent cartridge, 2160 Tests
Siemens Healthcare Diagnostics Inc.
10872082
In Commercial Distribution

  • 00630414595016 ()
  • 00630414006130 ()
K1033A

  • Creatinine IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge CRE2 - 00630414595009

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

  • 00630414595009 ()
  • 00630414006123 ()
DF33B

  • Creatinine IVD, kit, spectrophotometry

CLINITEK Advantus® Analyzer - 00630414593562

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
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