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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Insulin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310437
In Commercial Distribution

  • 00630414461007 ()
128432

  • Insulin IVD, control
Theophyline - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10328931
Not in Commercial Distribution

  • 00630414460963 ()
  • 00630414027661 ()
128380

  • Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Theophyline - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310434
Not in Commercial Distribution

  • 00630414460956 ()
128379

  • Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Theophylline - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10310432
Not in Commercial Distribution

  • 00630414460918 ()
128304

  • Theophylline therapeutic drug monitoring IVD, calibrator
TG Ab Dil.Ancill.RP (2PK) - CENTAUR - CONS - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310430
In Commercial Distribution

  • 00630414460833 ()
  • 00630414003368 ()
128280

  • Buffered sample diluent IVD
HIV RNA 3.0 Assay (bDNA) US IVD (Box 2)
Siemens Healthcare Diagnostics Inc.
10335367
Not in Commercial Distribution

  • 00630414457611 ()
127418B

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
HIV RNA 3.0 Assay (bDNA) US IVD (Box 1)
Siemens Healthcare Diagnostics Inc.
10335480
Not in Commercial Distribution

  • 00630414457604 ()
127418A

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Anti-TPO Dil.Ancill.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310391
In Commercial Distribution

  • 00630414457352 ()
  • 00630414003351 ()
125733

  • Buffered sample diluent IVD
Testosterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322623
Not in Commercial Distribution

  • 00630414454658 ()
  • 00630414010519 ()
125363

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Progesterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10315522
In Commercial Distribution

  • 00630414454641 ()
125362

  • Progesterone IVD, kit, chemiluminescent immunoassay
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