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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

ADVIA Centaur® Ancillary Probe Wash 1 - 00630414472898

Ancillary Probe Wash 12 pack - CENTAUR - CONS - 2x25mL
Siemens Healthcare Diagnostics Inc.
10309060
In Commercial Distribution

  • 00630414472898 ()
  • 00630414003030 ()
3395373

  • Buffered wash solution IVD

ADVIA Centaur® Systems HBsAg QC - 00630414472881

HBsAg (HBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309059
In Commercial Distribution

  • 00630414472881 ()
3394660

  • Hepatitis B virus surface antigen IVD, control

ADVIA Centaur® HBsAg Conf (Confirmatory) - 00630414472874

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

ADVIA Centaur® HBsAg - 00630414472867

HBsAg (HBs) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10309057
In Commercial Distribution

  • 00630414472867 ()
3393362

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems ACS:180® Systems BNP Calibrator - 00630414472836

BNP - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10309047
In Commercial Distribution

  • 00630414472836 ()
2817266

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

ADVIA Centaur® ACS:180® Systems BNP 1,2,3 QC - 00630414472829

BNP - CENTAUR - CONS - 3x3x2mL
Siemens Healthcare Diagnostics Inc.
10309046
In Commercial Distribution

  • 00630414472829 ()
2817045

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

ADVIA Centaur® BNP - 00630414472812

BNP - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10309045
In Commercial Distribution

  • 00630414472812 ()
  • 00630414003023 ()
2816634

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® BNP - 00630414472805

BNP - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309044
In Commercial Distribution

  • 00630414472805 ()
2816138

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® BNP MCM - 00630414472799

BNP Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309043
In Commercial Distribution

  • 00630414472799 ()
2815905

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

ADVIA Centaur® Systems iPTH Calibrator - 00630414472553

Intact PTH - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10309042
In Commercial Distribution

  • 00630414472553 ()
2698011

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA® 120/2120/2120i TESTpoint CSF Control Kit - 00630414472539

ADVIA®120/2120/2120i TESTpoint™ CSF Control Kit
Siemens Healthcare Diagnostics Inc.
10314243
In Commercial Distribution

  • 00630414472539 ()
T03-4485-01

  • Full blood count IVD, control

VERSANT® HCV RNA 3.0 ASSAY bDNA - 00630414472393

HCV RNA 3.0 Assay (bDNA) US IVD (Box 2)
Siemens Healthcare Diagnostics Inc.
10333501
Not in Commercial Distribution

  • 00630414472393 ()
2554338

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

VERSANT® HCV RNA 3.0 ASSAY bDNA - 00630414472386

HCV RNA 3.0 Assay (bDNA) US IVD (Box 1)
Siemens Healthcare Diagnostics Inc.
10333499
Not in Commercial Distribution

  • 00630414472386 ()
2553870

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ADVIA Centaur® aHBs - 00630414471914

Anti-HBs (aHBs) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10309021
Not in Commercial Distribution

  • 00630414471914 ()
1463789

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems aHBs QC - 00630414471860

Anti-HBs (aHBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309020
Not in Commercial Distribution

  • 00630414471860 ()
1453546

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur® H2n - 00630414471235

HER-2/neu - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10308994
In Commercial Distribution

  • 00630414471235 ()
915031

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® H2n Calibrator - 00630414471228

HER-2/Neu - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308993
In Commercial Distribution

  • 00630414471228 ()
913551

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator

ADVIA Centaur® H2n QC - 00630414471211

HER-2/Neu - CENTAUR - CONS - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308992
In Commercial Distribution

  • 00630414471211 ()
913276

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

RAPIDChem® 744 - 00630414471112

The Rapidchem® 744 analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), and Cl- (chloride) or Lithium (Li+) in serum, plasma, whole blood and urine (not applicable for Lithium) samples.
Siemens Healthcare Diagnostics Inc.
10324039
In Commercial Distribution

  • 00630414471112 ()
6254738

  • Ion-selective analyser IVD, semi-automated

ADVIA® Chemistry Direct LDL Cholesterol Reagents - 00630414470542

LDL Cholesterol - ADVIA Chem. - RGT - 4x188 tests
Siemens Healthcare Diagnostics Inc.
10311891
In Commercial Distribution

  • 00630414470542 ()
B01-4760-01

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