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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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For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in urine using the Clinitek Status® analyzer(qualitative)
Siemens Healthcare Diagnostics Inc.
10310618
In Commercial Distribution

  • 00630414473604 ()
1760

  • Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical
Hematek® Stain Pak Modified Wright's Stain
Siemens Healthcare Diagnostics Inc.
10310965
In Commercial Distribution

  • 00630414473499 ()
4481

  • Biological stain IVD
Hematek® Stain Pak Wright-Giemsa Stain
Siemens Healthcare Diagnostics Inc.
10314755
In Commercial Distribution

  • 00630414473482 ()
4405

  • Biological stain IVD
ADVIA®120/2120/2120i CSF REAGENT
Siemens Healthcare Diagnostics Inc.
10320459
In Commercial Distribution

  • 00630414473444 ()
T01-4610-01

  • Full blood count IVD, reagent
ADVIA®120/2120/2120i 3-in-1 TESTpoint™ High Control
Siemens Healthcare Diagnostics Inc.
10318905
In Commercial Distribution

  • 00630414473413 ()
T03-4418-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i 3 in 1 TESTpoint™ Low Control
Siemens Healthcare Diagnostics Inc.
10330063
In Commercial Distribution

  • 00630414473406 ()
T03-4417-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i 3-in-1 TESTpoint™ Norm Control
Siemens Healthcare Diagnostics Inc.
10316217
In Commercial Distribution

  • 00630414473390 ()
T03-4416-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i PEROX SHEATH
Siemens Healthcare Diagnostics Inc.
10312275
In Commercial Distribution

  • 00630414473383 ()
T01-3633-54

  • Full blood count IVD, reagent
HCV(aHCV) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309062
In Commercial Distribution

  • 00630414473178 ()
3439141

  • Hepatitis C virus total antibody IVD, control
HCV(aHCV) Assay Kit 200T
Siemens Healthcare Diagnostics Inc.
10309061
In Commercial Distribution

  • 00630414473161 ()
3438099

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Ancillary Probe Wash 12 pack - CENTAUR - CONS - 2x25mL
Siemens Healthcare Diagnostics Inc.
10309060
In Commercial Distribution

  • 00630414472898 ()
  • 00630414003030 ()
3395373

  • Buffered wash solution IVD
HBsAg (HBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309059
In Commercial Distribution

  • 00630414472881 ()
3394660

  • Hepatitis B virus surface antigen IVD, control
HBsAg Conf (Confirmatory) Assay Kit
Siemens Healthcare Diagnostics Inc.
10309058
In Commercial Distribution

  • 00630414472874 ()
3393818

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
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
Test tube, non-sterile
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10374179
In Commercial Distribution

  • 00630414982410 ()
905289

  • General specimen container IVD, no additive/medium
Test tube, non-sterile
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10374178
In Commercial Distribution

  • 00630414982403 ()
905288

  • General specimen container IVD, no additive/medium
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10697937
In Commercial Distribution

  • 00630414981147 ()
10697937

  • Urine analyser IVD, laboratory
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10494134
In Commercial Distribution

  • 00630414981130 ()
10494134

  • Urine analyser IVD, laboratory
Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995724
In Commercial Distribution

  • 00630414600376 ()
10995724

  • Multiple form 25-hydroxy Vitamin D IVD, control
Vitamin D total 25 (OH) (VitD) Atellica IM Master Curve Material Kit 5 x 2 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995723
In Commercial Distribution

  • 00630414600369 ()
10995723

  • Multiple form 25-hydroxy Vitamin D IVD, control
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