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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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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)

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

Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 - 00630414027968

Emit II Plus Specialty Multi Drug Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10720813
In Commercial Distribution

  • 00630414027968 ()
9T549UL

  • Multiple drugs of abuse IVD, calibrator

Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 - 00630414027951

Emit II Plus Specialty Multi Drug Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10720814
In Commercial Distribution

  • 00630414027951 ()
9T569UL

  • Multiple drugs of abuse IVD, calibrator

Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 - 00630414027944

Emit II Plus Specialty Multi Drug Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10720815
In Commercial Distribution

  • 00630414027944 ()
9T589UL

  • Multiple drugs of abuse IVD, calibrator

Emit II Plus Oxycodone Assay 115 mL Kit - 00630414027937

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720816
In Commercial Distribution

  • 00630414027937 ()
9T029UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Emit II Plus Oxycodone Assay 1 L Kit - 00630414027920

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720817
In Commercial Distribution

  • 00630414027920 ()
9T129UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

RAPIDPOINT®340/350 pH Electrode - 00630414566245

RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375796
In Commercial Distribution

  • 00630414566245 ()
10375796

  • Blood pH electrode

RAPIDPOINT® 340 Sensor Module - 00630414566238

RAPIDPOINT® 340 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 340 analyzer
Siemens Healthcare Diagnostics Inc.
10375809
In Commercial Distribution

  • 00630414566238 ()
10375809

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
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