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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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
Progesterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10315522
In Commercial Distribution

  • 00630414454641 ()
125362

  • Progesterone IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® TSTO (5-pack)
Siemens Healthcare Diagnostics Inc.
10339352
Not in Commercial Distribution

  • 00630414454535 ()
  • 00630414010571 ()
126346

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Progesterone (Ref) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10333111
In Commercial Distribution

  • 00630414454528 ()
  • 00630414010687 ()
126345

  • Progesterone IVD, kit, chemiluminescent immunoassay
RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution
Siemens Healthcare Diagnostics Inc.
10318630
In Commercial Distribution

  • 00630414452319 ()
3279837

  • Multiple blood gas analyte IVD, calibrator
Valve module an in vitro diagnostics device to be used on the RAPIDChem® 744/754 analyzer
Siemens Healthcare Diagnostics Inc.
10309056
In Commercial Distribution

  • 00630414452142 ()
3372381

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDChem® 700 Urine Diluent for in vitro use with Rapidchem® 700 systems. Contains: buffers & presevatives
Siemens Healthcare Diagnostics Inc.
10308995
In Commercial Distribution

  • 00630414452104 ()
938058

  • Buffered sample diluent IVD
RAPIDChem® 744 Daily Cleaner Kit, for in vitro diagnostics use with Rapidchem® 744 systems.
Siemens Healthcare Diagnostics Inc.
10309011
In Commercial Distribution

  • 00630414452098 ()
1331777

  • Wash/cleaning solution IVD, automated/semi-automated system
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