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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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CLINITEST® hCG Pregnancy Test - 00630414473604

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 - 00630414473499

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 - 00630414473482

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 - 00630414473444

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 - 00630414473413

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 - 00630414473406

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 Normal Control - 00630414473390

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 - 00630414473383

ADVIA®120/2120/2120i PEROX SHEATH
Siemens Healthcare Diagnostics Inc.
10312275
In Commercial Distribution

  • 00630414473383 ()
T01-3633-54

  • Full blood count IVD, reagent

ADVIA Centaur® Systems HCV QC - 00630414473178

HCV(aHCV) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309062
In Commercial Distribution

  • 00630414473178 ()
3439141

  • Hepatitis C virus total antibody IVD, control

ADVIA Centaur® HCV - 00630414473161

HCV(aHCV) Assay Kit 200T
Siemens Healthcare Diagnostics Inc.
10309061
In Commercial Distribution

  • 00630414473161 ()
3438099

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
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