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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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No Description
BIOCARE MEDICAL LLC
ACA342A
In Commercial Distribution

  • 00847627001474 ()


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
APA342AA
In Commercial Distribution

  • 00847627002013 ()


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
Her-2/neu (H2n) QC Kit Atellica IM - CLT 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995594
In Commercial Distribution

  • 00630414599182 ()
10995594

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Her-2/neu (H2n) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995593
In Commercial Distribution

  • 00630414599175 ()
10995593

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Her-2/neu (H2n) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995592
In Commercial Distribution

  • 00630414599168 ()
  • 00630414190952 ()
10995592

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator
HER2/ER/PR IHControls® - Level L are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
Boston Cell Standards Inc
Level L
In Commercial Distribution

  • 00850045519025 ()
BRL2W08

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
HER2/ER/PR IHControls® - Level M are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
Boston Cell Standards Inc
Level M
In Commercial Distribution

  • 00850045519018 ()
BRL2U04

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
HER2/ER/PR IHControls® - Level H are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
Boston Cell Standards Inc
Level H
In Commercial Distribution

  • 00850045519001 ()
BRLS11

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Clone CB11
NOVODIAX, INC.
AP31063-004
In Commercial Distribution

  • 00850041202419 ()

  • Total Volume: 4 Milliliter
AP31063-004

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
Polyclonal Rabbit Anti-Human c-erbB-2 Oncoprotein
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0485
In Commercial Distribution

  • 05700572515456 ()

  • Total Volume: 0.2 Milliliter


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
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