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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LOCI Vitamin B12 Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10463371
In Commercial Distribution

  • 00630414976624 ()
  • 00630414005508 ()
RF642

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
LOCI Folate Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10463370
In Commercial Distribution

  • 00630414976617 ()
  • 00630414005492 ()
RF644

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380037
In Commercial Distribution

  • 00630414974187 ()
LSCP

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385210
In Commercial Distribution

  • 00630414973159 ()
L2ZT

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385211
In Commercial Distribution

  • 00630414972923 ()
L2ZC

  • General specimen container IVD, no additive/medium
The Stratus® CS Acute Care(TM) D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10701511
In Commercial Distribution

  • 00630414986166 ()
  • 00630414010014 ()
CDDMRE

  • D-dimer IVD, kit, fluorescent immunoassay
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385183
In Commercial Distribution

  • 00630414974194 ()
LSCC

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385205
In Commercial Distribution

  • 00630414974064 ()
LSMC

  • General specimen container IVD, no additive/medium
Microsampling Tubes - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385207
In Commercial Distribution

  • 00630414973937 ()
LMST

  • General specimen container IVD, no additive/medium
Allergen Tube Septa
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10282849
In Commercial Distribution

  • 00630414965741 ()
L2ATS2

  • General specimen container IVD, no additive/medium
IMMULITE® 2000 Systems Allergen Tube Cap
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10282837
In Commercial Distribution

  • 00630414965734 ()
L2ATC

  • General specimen container IVD, no additive/medium
LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator
Fructosamine - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285684
Not in Commercial Distribution

  • 00630414558240 ()
  • 00630414002996 ()
4865217

  • Fructosamine IVD, calibrator
Myoglobin Kit - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285682
Not in Commercial Distribution

  • 00630414558233 ()
4865160

  • Myoglobin IVD, calibrator
B2 Microglobulin - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10285680
Not in Commercial Distribution

  • 00630414558226 ()
  • 00630414002989 ()
4865101

  • Beta-2-microglobulin IVD, calibrator
Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Fructosamine - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361941
Not in Commercial Distribution

  • 00630414558073 ()
4862501

  • Fructosamine IVD, kit, spectrophotometry
Cystatin C - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10361930
Not in Commercial Distribution

  • 00630414557915 ()
4851534

  • Cystatin C IVD, kit, nephelometry/turbidimetry
SHBG - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10285318
Not in Commercial Distribution

  • 00630414556093 ()
4819274

  • Sex hormone binding globulin (SHBG) IVD, calibrator
Calcium - ADVIA Chem. - RGT - 6x675 tests
Siemens Healthcare Diagnostics Inc.
10286036
In Commercial Distribution

  • 00630414555904 ()
4802312

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Ammonia - ADVIA Chem. - RGT - 2x138 tests
Siemens Healthcare Diagnostics Inc.
10286035
In Commercial Distribution

  • 00630414555898 ()
4802290

  • Ammonia IVD, kit, spectrophotometry
VERSANT® Sample Preparation 1.0 Reagents (Box 2)
Siemens Healthcare Diagnostics Inc.
10286027
In Commercial Distribution

  • 00630414555553 ()
4801685

  • Nucleic acid extraction/isolation kit IVD
VERSANT® Sample Preparation 1.0 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10286026
In Commercial Distribution

  • 00630414555546 ()
4801677

  • Nucleic acid extraction/isolation kit IVD
Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285905
In Commercial Distribution

  • 00630414555331 ()
4800840

  • Multiple human hormone IVD, calibrator
Thyroid (6PK) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285904
In Commercial Distribution

  • 00630414555324 ()
4800735

  • Multiple human hormone IVD, calibrator
Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10285903
In Commercial Distribution

  • 00630414555317 ()
4800646

  • Multiple human hormone IVD, calibrator
aHBs2 Master Curve Material
Siemens Healthcare Diagnostics Inc.
10285962
In Commercial Distribution

  • 00630414555300 ()
4800387

  • Hepatitis B virus surface total antibody IVD, control
HbA1C Denaturant - ADVIA Chem. - CONS - 920mL (for 920 Tests)
Siemens Healthcare Diagnostics Inc.
10286032
Not in Commercial Distribution

  • 00630414555140 ()
4795367

  • Glycated haemoglobin (HbA1c) IVD, reagent
T3 Total (Ref) - CENTAUR - RGT - 400 tests
Siemens Healthcare Diagnostics Inc.
10285734
In Commercial Distribution

  • 00630414554631 ()
  • 00630414010700 ()
4779779

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
T3 Total - CENTAUR - RGT - 80 tests
Siemens Healthcare Diagnostics Inc.
10285733
In Commercial Distribution

  • 00630414554624 ()
4779671

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
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