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 Class Implantable

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Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 4
Siemens Healthcare Diagnostics Inc.
10720052
In Commercial Distribution

  • 00630414601168 ()
9S589UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 3
Siemens Healthcare Diagnostics Inc.
10720051
In Commercial Distribution

  • 00630414601151 ()
9S569UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 2
Siemens Healthcare Diagnostics Inc.
10720050
In Commercial Distribution

  • 00630414601144 ()
9S549UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 1
Siemens Healthcare Diagnostics Inc.
10720049
In Commercial Distribution

  • 00630414601137 ()
9S529UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus Buprenorphine Assay – 28 mL kit
Siemens Healthcare Diagnostics Inc.
10720048
In Commercial Distribution

  • 00630414601120 ()
9S039UL

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Buprenorphine Assay - 115 mL kit
Siemens Healthcare Diagnostics Inc.
10720047
In Commercial Distribution

  • 00630414601113 ()
9S029UL

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Buprenorphine Assay - 1L kit
Siemens Healthcare Diagnostics Inc.
10720046
In Commercial Distribution

  • 00630414601106 ()
9S129UL

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Buprenorphine Control Positive
Siemens Healthcare Diagnostics Inc.
10718701
In Commercial Distribution

  • 00630414601090 ()
9S619UL

  • Multiple drugs of abuse IVD, control
Syva® Emit® II Plus Buprenorphine Control Negative
Siemens Healthcare Diagnostics Inc.
10718700
In Commercial Distribution

  • 00630414601083 ()
9S609UL

  • Multiple drugs of abuse IVD, control
ADVIA® Chemistry Reagent Wedge 20 mL
Siemens Healthcare Diagnostics Inc.
10487137
In Commercial Distribution

  • 00630414601052 ()
073-0372-03

  • Assay container IVD, single-use
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