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® Calibrator B Level 1 (cutoff)
Siemens Healthcare Diagnostics Inc.
10445412
In Commercial Distribution

  • 00842768001796 ()
9A879UL

  • Amphetamine/methamphetamine group IVD, calibrator
Syva® Emit® Calibrator/Control Level 5
Siemens Healthcare Diagnostics Inc.
10445411
In Commercial Distribution

  • 00842768001789 ()
9A609UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10445410
In Commercial Distribution

  • 00842768001772 ()
9A589UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10445409
In Commercial Distribution

  • 00842768001765 ()
9A569UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10445408
In Commercial Distribution

  • 00842768001758 ()
9A549UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10445407
In Commercial Distribution

  • 00842768001741 ()
9A529UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator/Control Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445406
In Commercial Distribution

  • 00842768001734 ()
9A509UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445403
In Commercial Distribution

  • 00842768001703 ()
9A049UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® 2000 Tacrolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445399
In Commercial Distribution

  • 00842768001680 ()
8R109UL

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Tacrolimus Assay
Siemens Healthcare Diagnostics Inc.
10445397
In Commercial Distribution

  • 00842768001666 ()
8R019UL

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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