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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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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
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.
18 test
In Commercial Distribution

  • 08887581000009 ()
0711088018

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
BIOMERICA, INC.
1009-15
Not in Commercial Distribution

  • 08305901009155 ()


  • Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
BIOMERICA, INC.
1009-15
In Commercial Distribution

  • 00083059100952 ()


  • Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)
Abbott RealTime IDH2 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
08N82-090
In Commercial Distribution

  • 00884999047044 ()
08N82-090

  • Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, kit, nucleic acid technique (NAT)
Kelly Retractor 2" x 2 1/2"
Automated Medical Products Corp.
Kelly Retractor 2" x 2 1/2"
In Commercial Distribution

  • 00810118341779 ()
1558 00 SS

  • Surgical retractor/retraction system blade, reusable
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