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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RAPIDLyte Multicap-S plastic blood collection capillary tubes (50 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10313252
In Commercial Distribution

  • 00630414511511 ()
  • 00630414009391 ()
335434

  • Capillary blood collection tube IVD, no additive
HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10332613
In Commercial Distribution

  • 00630414511245 ()
1622429

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10315219
In Commercial Distribution

  • 00630414510293 ()
  • 00630414010137 ()
1428622

  • Calcium (Ca2+) electrode IVD
Pyridoxal-5-Phosphate Reagents
Siemens Healthcare Diagnostics Inc.
10315181
In Commercial Distribution

  • 00630414510163 ()
  • 00630414003498 ()
1411533

  • Alanine aminotransferase (ALT) IVD, reagent
Amylase pancreatic - ADVIA Chem. - RGT - 7x130 tests
Siemens Healthcare Diagnostics Inc.
10315178
In Commercial Distribution

  • 00630414510156 ()
1410820

  • Amylase isoenzyme IVD, kit, spectrophotometry
PCHE - ADVIA Chem. - RGT - 4x234 tests
Siemens Healthcare Diagnostics Inc.
10315176
In Commercial Distribution

  • 00630414510149 ()
1410545

  • Acetylcholinesterase IVD, kit, spectrophotometry
Lithium - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10312850
Not in Commercial Distribution

  • 00630414509778 ()
141230

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Atellica CH Diazo Direct Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537219
In Commercial Distribution

  • 00630414313429 ()
  • 00630414614755 ()
11537219

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Atellica IM Base solution
Siemens Healthcare Diagnostics Inc.
11417930
In Commercial Distribution

  • 00630414613437 ()
  • 00630414317014 ()
11417930

  • Chemiluminescent immunoassay signal generation kit IVD
Atellica IM Acid
Siemens Healthcare Diagnostics Inc.
11417929
In Commercial Distribution

  • 00630414613239 ()
  • 00630414317007 ()
11417929

  • Chemiluminescent immunoassay signal generation kit IVD
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