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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EGFR pharmDx for Autostainer
AGILENT TECHNOLOGIES, INC.
K1494
Not in Commercial Distribution

  • 05700571103982 ()

  • 50 Tests


  • Epidermal growth factor receptor (EGFR) IVD, kit, enzyme immunohistochemistry
EGFR pharmDx
AGILENT TECHNOLOGIES, INC.
K1492
Not in Commercial Distribution

  • 05700571103968 ()

  • 35 Tests


  • Epidermal growth factor receptor (EGFR) IVD, kit, enzyme immunohistochemistry
Monoclonal Mouse Anti-Human Renal Cell Carcinoma Clone SPM314
AGILENT TECHNOLOGIES, INC.
M3632
Not in Commercial Distribution

  • 05700571102619 ()

  • Total Volume: 1 Milliliter


  • Renal cell carcinoma antigen IVD, antibody
Monoclonal Mouse Anti-Human CD15 Clone Carb-3
AGILENT TECHNOLOGIES, INC.
M3631
In Commercial Distribution

  • 05700571102596 ()

  • Total Volume: 1 Milliliter


  • CD15 cell marker IVD, antibody
Monoclonal Mouse Anti-Human CD15 Clone Carb-3
AGILENT TECHNOLOGIES, INC.
M3631
In Commercial Distribution

  • 05700571102589 ()

  • Total Volume: 0.2 Milliliter


  • CD15 cell marker IVD, antibody
Monoclonal Mouse Anti-Human PTEN Clone 6H2.1
AGILENT TECHNOLOGIES, INC.
M3627
In Commercial Distribution

  • 05700571102534 ()

  • Total Volume: 0.2 Milliliter


  • Phosphatase and tensin homolog (PTEN) protein IVD, antibody
Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5
AGILENT TECHNOLOGIES, INC.
M3625
Not in Commercial Distribution

  • 05700571102527 ()

  • Total Volume: 0.2 Milliliter


  • Mammaglobin IVD, antibody
Monoclonal Mouse Anti-Human Survivin Clone 12C4
AGILENT TECHNOLOGIES, INC.
M3624
Not in Commercial Distribution

  • 05700571102510 ()

  • Total Volume: 0.2 Milliliter


  • Survivin protein IVD, antibody
Monoclonal Mouse Anti-Human Tyrosinase Clone T311
AGILENT TECHNOLOGIES, INC.
M3623
In Commercial Distribution

  • 05700571102503 ()

  • Total Volume: 0.2 Milliliter


  • Tyrosinase IVD, antibody
Monoclonal Mouse Anti-Human MITF (Microphthalmia Transcription Factor) Clone D5
AGILENT TECHNOLOGIES, INC.
M3621
In Commercial Distribution

  • 05700571102480 ()

  • Total Volume: 0.2 Milliliter


  • Microphthalmia-associated transcription factor (MITF) IVD, antibody
Monoclonal Mouse Anti-Human Prostate-Specific Membrane Antigen Clone 3E6
AGILENT TECHNOLOGIES, INC.
M3620
Not in Commercial Distribution

  • 05700571102473 ()

  • Total Volume: 0.2 Milliliter


  • Prostate-specific membrane antigen (PSMA) IVD, antibody
Monoclonal Mouse Anti-Human Podoplanin Clone D2-40
AGILENT TECHNOLOGIES, INC.
M3619
In Commercial Distribution

  • 05700571102466 ()

  • Total Volume: 1 Milliliter


  • D2-40 antigen IVD, antibody
Monoclonal Mouse Anti-Human Podoplanin Clone D2-40
AGILENT TECHNOLOGIES, INC.
M3619
In Commercial Distribution

  • 05700571102459 ()

  • Total Volume: 0.2 Milliliter


  • D2-40 antigen IVD, antibody
Monoclonal Mouse Anti-Human COX-2 Clone CX-294
AGILENT TECHNOLOGIES, INC.
M3617
Not in Commercial Distribution

  • 05700571102442 ()

  • Total Volume: 1 Milliliter


  • Cox-2 IVD, antibody
Monoclonal Mouse Anti-Human Thymidylate Synthase (TS) Clone TS106
AGILENT TECHNOLOGIES, INC.
M3614
Not in Commercial Distribution

  • 05700571102428 ()

  • Total Volume: 1 Milliliter


  • Thymidylate synthase IVD, antibody
Monoclonal Mouse Anti-Human E-cadherin Clone NCH-38
AGILENT TECHNOLOGIES, INC.
M3612
In Commercial Distribution

  • 05700571102404 ()

  • Total Volume: 1 Milliliter


  • Cadherin protein IVD, antibody
Monoclonal Mouse Anti-Human E-cadherin Clone NCH-38
AGILENT TECHNOLOGIES, INC.
M3612
In Commercial Distribution

  • 05700571102398 ()

  • Total Volume: 0.2 Milliliter


  • Cadherin protein IVD, antibody
Monoclonal Mouse Anti-Thyroid Transcription Factor (TTF-1) Clone 8G7G3/1
AGILENT TECHNOLOGIES, INC.
M3575
In Commercial Distribution

  • 05700571102343 ()

  • Total Volume: 1 Milliliter


  • Thyroid transcription factor-1 (TTF1) IVD, antibody
Monoclonal Mouse Anti-Human CD1a Clone 010
AGILENT TECHNOLOGIES, INC.
M3571
Not in Commercial Distribution

  • 05700571102329 ()

  • Total Volume: 1 Milliliter


  • CD1a cell marker IVD, antibody
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636
AGILENT TECHNOLOGIES, INC.
M3569
In Commercial Distribution

  • 05700571102305 ()

  • Total Volume: 1 Milliliter


  • Estrogen (oestrogen)/progesterone receptor IVD, antibody
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636
AGILENT TECHNOLOGIES, INC.
M3569
In Commercial Distribution

  • 05700571102299 ()

  • Total Volume: 0.2 Milliliter


  • Estrogen (oestrogen)/progesterone receptor IVD, antibody
Monoclonal Mouse Anti-Human Epidermal Growth Factor Receptor (EGFR) Clone: H11
AGILENT TECHNOLOGIES, INC.
M3563
Not in Commercial Distribution

  • 05700571102268 ()

  • Total Volume: 1 Milliliter


  • Epidermal growth factor receptor (EGFR) IVD, antibody
Monoclonal Mouse Anti-Human Androgen Receptor Clone AR441
AGILENT TECHNOLOGIES, INC.
M3562
In Commercial Distribution

  • 05700571102251 ()

  • Total Volume: 1 Milliliter


  • Androgen receptor IVD, antibody
Monoclonal Mouse Anti-Human Wilms' Tumor 1 (WT1) Protein Clone 6F-H2
AGILENT TECHNOLOGIES, INC.
M3561
In Commercial Distribution

  • 05700571102244 ()

  • Total Volume: 1 Milliliter


  • Wilms tumour protein IVD, antibody
Monoclonal Mouse Anti-Human Calponin Clone CALP
AGILENT TECHNOLOGIES, INC.
M3556
In Commercial Distribution

  • 05700571102206 ()

  • Total Volume: 1 Milliliter


  • Calponin protein IVD, antibody
Monoclonal Mouse Anti-Human Beta-Catenin Clone ß-Catenin-1
AGILENT TECHNOLOGIES, INC.
M3539
In Commercial Distribution

  • 05700571102190 ()

  • Total Volume: 1 Milliliter


  • Beta-catenin IVD, antibody
Monoclonal Mouse Anti-Human Papillomavirus (HPV) Clone K1H8
AGILENT TECHNOLOGIES, INC.
M3528
In Commercial Distribution

  • 05700571102176 ()

  • Total Volume: 1 Milliliter


  • Human papillomavirus (HPV) antigen IVD, antibody
Monoclonal Mouse Anti-Human Epithelial Related Antigen Clone MOC-31
AGILENT TECHNOLOGIES, INC.
M3525
In Commercial Distribution

  • 05700571102145 ()

  • Total Volume: 1 Milliliter


  • Epithelial-related antigen IVD, antibody
Monoclonal Mouse Anti-Human CA 19-9 Clone 1116-NS-19-9
AGILENT TECHNOLOGIES, INC.
M3517
In Commercial Distribution

  • 05700571102121 ()

  • Total Volume: 1 Milliliter


  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
Monoclonal Mouse Anti-Human Cytokeratin Clones AE1/AE3
AGILENT TECHNOLOGIES, INC.
M3515
In Commercial Distribution

  • 05700571102114 ()

  • Total Volume: 1 Milliliter


  • Cytokeratin IVD, antibody
Monoclonal Mouse Anti-Human Cytokeratin Clones AE1/AE3
AGILENT TECHNOLOGIES, INC.
M3515
In Commercial Distribution

  • 05700571102107 ()

  • Total Volume: 0.2 Milliliter


  • Cytokeratin IVD, antibody
Monoclonal Mouse Anti-MyoD1 Clone 5.8A
AGILENT TECHNOLOGIES, INC.
M3512
Not in Commercial Distribution

  • 05700571102091 ()

  • Total Volume: 1 Milliliter


  • Myogenin IVD, antibody
Monoclonal Mouse Anti-Human Mesothelial Cell Clone HBME-1
AGILENT TECHNOLOGIES, INC.
M3505
In Commercial Distribution

  • 05700571102060 ()

  • Total Volume: 1 Milliliter


  • Mesothelial cell IVD, antibody
Monoclonal Mouse Anti-Human Follicle Stimulating Hormone (FSH) Clone C10
AGILENT TECHNOLOGIES, INC.
M3504
In Commercial Distribution

  • 05700571102053 ()

  • Total Volume: 1 Milliliter


  • Follicle stimulating hormone (FSH) IVD, antibody
Monoclonal Mouse Anti-Human Thyroid Stimulating Hormone (TSH) Clone 0042
AGILENT TECHNOLOGIES, INC.
M3503
Not in Commercial Distribution

  • 05700571102046 ()

  • Total Volume: 1 Milliliter


  • Thyroid stimulating hormone (TSH) IVD, antibody
Monoclonal Mouse Anti-Human Luteinizing Hormone (LH) Clone C93
AGILENT TECHNOLOGIES, INC.
M3502
In Commercial Distribution

  • 05700571102039 ()

  • Total Volume: 1 Milliliter


  • Luteinizing hormone (LH) IVD, antibody
Monoclonal Mouse Anti-Adrenocorticotropin (ACTH) Clone 02A3
AGILENT TECHNOLOGIES, INC.
M3501
In Commercial Distribution

  • 05700571102022 ()

  • Total Volume: 1 Milliliter


  • Adrenocorticotropic hormone (ACTH) IVD, antibody
Monoclonal Mouse Anti-Human Laminin Clone 4C7
AGILENT TECHNOLOGIES, INC.
M0638
Not in Commercial Distribution

  • 05700571102008 ()

  • Total Volume: 1 Milliliter


  • Laminin IVD, antibody
Monoclonal Mouse Anti-Human Muscle Actin Clone HHF35
AGILENT TECHNOLOGIES, INC.
M0635
Not in Commercial Distribution

  • 05700571101995 ()

  • Total Volume: 1 Milliliter


  • Muscle-specific alpha/gamma actin IVD, antibody
Monoclonal Mouse Anti-Human Melanosome Clone HMB45
AGILENT TECHNOLOGIES, INC.
M0634
In Commercial Distribution

  • 05700571101988 ()

  • Total Volume: 1 Milliliter


  • Melanosome IVD, antibody
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