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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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Symmetry® Dilator; Cooley Coronary; 2.0 mm Tip
SYMMETRY SURGICAL INC.
55-7120
In Commercial Distribution

  • 00887482085547 ()

  • Shaft Length: 2 Millimeter
55-7120

  • Vascular dilator, reusable
No Description
Bion Enterprises, Ltd.
HS2-4012
In Commercial Distribution

  • B110HS240120 ()
HS2-4012

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, reagent
PRECICHEK AutoCode Blood Glucose ACH foil packed test strip
HMD BIOMEDICAL INC.
3L-10-16003B
In Commercial Distribution

  • 04260236851210 ()
  • 04260236851142 ()
3L-10-16003B

  • Glucose IVD, kit, electrometry
  • Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control
HER-2/neu - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10308994
In Commercial Distribution

  • 00630414471235 ()
915031

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay
Her-2/neu (H2n) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995591
In Commercial Distribution

  • 00630414599151 ()
10995591

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay
HercepTest for Automated Link Platforms
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
SK001
In Commercial Distribution

  • 05700572032007 ()

  • 50 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
HercepTest for the Dako Autostainer
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5207
Not in Commercial Distribution

  • 05700572031994 ()

  • 50 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
HercepTest
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5204
Not in Commercial Distribution

  • 05700572031987 ()

  • 35 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation.
LEICA BIOSYSTEMS NEWCASTLE LTD
TA9145
In Commercial Distribution

  • 05055331301291 ()
TA9145

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
36 test
In Commercial Distribution

  • 08887581000016 ()
07110888036

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
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