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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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LA 1 Screening Reagent - 00630414639765

LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873904
In Commercial Distribution

  • 00842768019654 ()
  • 00630414639765 ()
10873904

  • Lupus anticoagulant marker IVD, reagent

Atellica IM Base - 00630414613437

Atellica IM Base solution
Siemens Healthcare Diagnostics Inc.
11417930
In Commercial Distribution

  • 00630414613437 ()
  • 00630414317014 ()
11417930

  • Chemiluminescent immunoassay signal generation kit IVD

Atellica IM Acid - 00630414613239

Atellica IM Acid
Siemens Healthcare Diagnostics Inc.
11417929
In Commercial Distribution

  • 00630414613239 ()
  • 00630414317007 ()
11417929

  • Chemiluminescent immunoassay signal generation kit IVD

A-LYTE IMT Cleaner - 00630414611617

A-LYTE IMT Cleaner
Siemens Healthcare Diagnostics Inc.
11556782
In Commercial Distribution

  • 00630414302751 ()
  • 00630414611617 ()
11556782

  • Wash/cleaning solution IVD, automated/semi-automated system

Atellica CH Cholinesterase_2 - 00630414611044

Cholinestrase (CHE_2) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537221
In Commercial Distribution

  • 00630414305042 ()
  • 00630414611044 ()
11537221

  • Pseudocholinesterase IVD, kit, spectrophotometry

Atellica CH LDLC - 00630414611037

LDL Cholesterol (LDLC) Atellica CH Assay 1600 Tests
Siemens Healthcare Diagnostics Inc.
11537214
In Commercial Distribution

  • 00630414305073 ()
  • 00630414611037 ()
11537214

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

Atellica CH Lactate_3 - 00630414610979

Lactate_3 (LAC_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537218
In Commercial Distribution

  • 00630414305066 ()
  • 00630414610979 ()
11537218

  • Lactate IVD, kit, spectrophotometry

Atellica CH Trig_2 - 00630414610955

Triglycerides_2 (Trig_2) Atellica CH Assay 2000 Tests
Siemens Healthcare Diagnostics Inc.
11537222
In Commercial Distribution

  • 00630414305110 ()
  • 00630414610955 ()
11537222

  • Triglyceride IVD, kit, spectrophotometry

Atellica CH Anti-Streptolysin-O_3 (ASO_3) - 00630414610856

Antistreptolysin O (ASO_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537212
In Commercial Distribution

  • 00630414305097 ()
  • 00630414610856 ()
11537212

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Atellica CH Iron3 (Iron3) - 00630414610849

Iron (Iron3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537211
In Commercial Distribution

  • 00630414305011 ()
  • 00630414610849 ()
11537211

  • Iron IVD, kit, spectrophotometry
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