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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Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator
Lipoprotein a (LP(a)) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099433
In Commercial Distribution

  • 00630414597546 ()
11099433

  • Lipoprotein A IVD, calibrator
LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator
NCL-L-InhibinA-U is intended for the qualitative identification by light microscopy of inhibin alpha molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
INHIBINA-L-U
In Commercial Distribution

  • 05055331333889 ()
NCL-L-INHIBINA-U

  • Inhibin A IVD, antibody
NCL-L-CHROM-430-U is intended for the qualitative identification by light microscopy of chromogranin A molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CHROM-430-L-U
In Commercial Distribution

  • 05055331333537 ()
NCL-L-CHROM-430-U

  • Chromogranin A IVD, antibody
Napsin A (IP64) antibody is intended to be used for the qualitative identification by light microscopy of napsin A molecules in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0064
In Commercial Distribution

  • 05055331326485 ()
PA0064

  • Napsin A IVD, antibody
NCL-L-CHROM-430 is intended for the qualitative identification by light microscopy of chromogranin A molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CHROM-430-L-CE
In Commercial Distribution

  • 05055331326478 ()
NCL-L-CHROM-430

  • Chromogranin A IVD, antibody
Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human chromogranin A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0515-U
In Commercial Distribution

  • 05055331335197 ()
PA0515-U

  • Chromogranin A IVD, antibody
Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0488-U
In Commercial Distribution

  • 05055331335166 ()
PA0448-U

  • Inhibin A IVD, antibody
Napsin A (IP64) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human napsin A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0064-U
In Commercial Distribution

  • 05055331334312 ()
PA0064-U

  • Napsin A IVD, antibody
NCL-L-NapsinA-U is intended for the qualitative identification by light microscopy of Napsin A molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-U
In Commercial Distribution

  • 05055331334039 ()
NCL-L-NAPSINA-U

  • Napsin A IVD, antibody
Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0488
In Commercial Distribution

  • 05055331327000 ()
PA0488

  • Inhibin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
CM171B
In Commercial Distribution

  • 00847627006714 ()


  • Inhibin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
CM171C
In Commercial Distribution

  • 00847627006721 ()


  • Inhibin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3043AA
In Commercial Distribution

  • 00847627004000 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3043C
In Commercial Distribution

  • 00847627002778 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3043A
In Commercial Distribution

  • 00847627002761 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271M-18
In Commercial Distribution

  • 00841683132134 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271M-17
In Commercial Distribution

  • 00841683132127 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271M-16
In Commercial Distribution

  • 00841683132110 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271M-15
In Commercial Distribution

  • 00841683132103 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271M-14
In Commercial Distribution

  • 00841683132097 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
238M-98
In Commercial Distribution

  • 00841683129509 ()


  • Chromogranin A IVD, antibody
No Description
CELL MARQUE CORPORATION
238M-97
In Commercial Distribution

  • 00841683129493 ()


  • Chromogranin A IVD, antibody
No Description
CELL MARQUE CORPORATION
238M-96
In Commercial Distribution

  • 00841683129486 ()


  • Chromogranin A IVD, antibody
No Description
CELL MARQUE CORPORATION
238M-95
In Commercial Distribution

  • 00841683129479 ()


  • Chromogranin A IVD, antibody
No Description
CELL MARQUE CORPORATION
238M-94
In Commercial Distribution

  • 00841683129462 ()


  • Chromogranin A IVD, antibody
No Description
CELL MARQUE CORPORATION
238M-90
In Commercial Distribution

  • 00841683129455 ()


  • Chromogranin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352R-18
In Commercial Distribution

  • 00841683138228 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352R-17
In Commercial Distribution

  • 00841683138211 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352R-15
In Commercial Distribution

  • 00841683138204 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352M-98
In Commercial Distribution

  • 00841683138198 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352M-97
In Commercial Distribution

  • 00841683138181 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352M-95
In Commercial Distribution

  • 00841683138174 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352A-78
In Commercial Distribution

  • 00841683138167 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352A-77
In Commercial Distribution

  • 00841683138150 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352A-76
In Commercial Distribution

  • 00841683138143 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352A-75
In Commercial Distribution

  • 00841683138136 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352A-74
In Commercial Distribution

  • 00841683138129 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
760-6081
In Commercial Distribution

  • 00841683119883 ()


  • Inhibin A IVD, antibody
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