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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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ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002866

ADVIA A1c_E Reagent (Large Kit), 1200 tests
Siemens Healthcare Diagnostics Inc.
10720858
In Commercial Distribution

  • 00630414002866 ()
10720858

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002859

ADVIA A1c_E Reagent (Small Kit), 300 tests
Siemens Healthcare Diagnostics Inc.
10720857
In Commercial Distribution

  • 00630414002859 ()
10720857

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

Atellica CH MULTIDRUG QC - 00630414002699

Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL
Siemens Healthcare Diagnostics Inc.
11099406
Not in Commercial Distribution

  • 00630414002699 ()
  • 00630414211572 ()
11099406

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Atellica Sample Handler Additional - 00630414002460

Atellica SAMPLE HANDLER ADDITIONAL MODULE
Siemens Healthcare Diagnostics Inc.
11069004
In Commercial Distribution

  • 00630414002460 ()
11069004

  • Specimen processing instrument IVD

Atellica Sample Handler Prime - 00630414002439

Atellica SAMPLE HANDLER PRIMARY MODULE
Siemens Healthcare Diagnostics Inc.
11069001
In Commercial Distribution

  • 00630414002439 ()
11069001

  • Specimen processing instrument IVD

Atellica Direct Load Kit - 00630414002354

Atellica DL PRIMARY KIT
Siemens Healthcare Diagnostics Inc.
11068009
In Commercial Distribution

  • 00630414002354 ()
11068009

  • Specimen processing instrument IVD

Atellica Direct Load - 00630414002347

Atellica DL MODULE
Siemens Healthcare Diagnostics Inc.
11068008
In Commercial Distribution

  • 00630414002347 ()
11068008

  • Specimen processing instrument IVD

Atellica CH 930 Analyzer - 00630414002163

Atellica CH 930 Analyzer
Siemens Healthcare Diagnostics Inc.
11067000
In Commercial Distribution

  • 00630414002163 ()
11067000

  • Multiple clinical chemistry analyser IVD, laboratory

Atellica IM 1600 Analyzer - 00630414002026

Atellica IM 1600 Analyzer
Siemens Healthcare Diagnostics Inc.
11066000
In Commercial Distribution

  • 00630414002026 ()
11066000

  • Chemiluminescent immunoassay analyser IVD

Xprecia Stride™ Accessory Kit - 00630414001975

Stride Device Manager Application software kit
Siemens Healthcare Diagnostics Inc.
10714617
In Commercial Distribution

  • 00630414001975 ()
10714617

  • Medical equipment clinical data interfacing software

ADVIA Chemistry CO2_c - 00630414000541

ADVIA Chemistry CO2_c 20mL
Siemens Healthcare Diagnostics Inc.
10720780
In Commercial Distribution

  • 00630414000541 ()
  • 00630414300122 ()
10720780

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry

VERSANT - 00630414000534

LiPAScan software
Siemens Healthcare Diagnostics Inc.
10492006
In Commercial Distribution

  • 00630414000534 ()
10492006

  • Laboratory instrument/analyser application software IVD

VERSANT HCV Control 2.0 Kit (LiPA) - 00630414000510

VERSANT HCV Control 2.0 Kit
Siemens Healthcare Diagnostics Inc.
10719668
In Commercial Distribution

  • 00630414000510 ()
10719668

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

VERSANT HCV 2.0 LiPA - 00630414000503

VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719667
In Commercial Distribution

  • 00630414000503 ()
10719667

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

VERSANT HCV 2.0 LiPA - 00630414000497

VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719666
In Commercial Distribution

  • 00630414000497 ()
10719666

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

RAPIDComm® Data Management System - 00630414000466

The RAPIDComm® program manages the process of sending and receiving data from devices and hospital systems located anywhere in your network.
Siemens Healthcare Diagnostics Inc.
11065134
In Commercial Distribution

  • 00630414000466 ()
11065134

  • Medical equipment clinical data interfacing software

ADVIA Autoslide® Slide Maker Stainer - 00630414000220

ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10282178
In Commercial Distribution

  • 00630414000220 ()
085-A002-03

  • Microscope slide maker/stainer IVD

ADVIA® Chemistry MYO Myoglobin Reagents - 00630414000190

Myoglobin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361939
Not in Commercial Distribution

  • 00630414000190 ()
4862455

  • Myoglobin IVD, kit, nephelometry/turbidimetry

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
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