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 Class Implantable

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Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995520
In Commercial Distribution

  • 00630414598475 ()
  • 00630414190914 ()
10995520

  • Complexed prostate specific antigen (cPSA) IVD, calibrator
Uric Acid (UA) Atellica CH - RGT 4800T
Siemens Healthcare Diagnostics Inc.
11097608
In Commercial Distribution

  • 00630414596334 ()
11097608

  • Uric acid IVD, kit, spectrophotometry
Amphetamine (Amp) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097506
In Commercial Distribution

  • 00630414596068 ()
11097506

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Acetaminophen (Acet) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097522
In Commercial Distribution

  • 00630414595894 ()
11097522

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Lipoprotein A (LP(a)) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097627
In Commercial Distribution

  • 00630414595559 ()
11097627

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
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
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
CCP IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10699141
In Commercial Distribution

  • 00630414592312 ()
10699141

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator
Rinse additive for CLINITEK Novus® automated urine chemistry system.
Siemens Healthcare Diagnostics Inc.
10697754
In Commercial Distribution

  • 00630414590936 ()
  • 00630414010007 ()
10697754

  • Buffered wash solution IVD
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