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- MiscellaneousMiscellaneous
- MAODna-Probe, Human ChromosomeUProduct Code
- MKQProcessor, Cervical Cytology Slide, Automated3Product Code
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- MTIKit, Cell Screening, FetalNProduct Code
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- PKWImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase3Product Code
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- QFISynthetic Next-Generation Sequencing Quality Control And Filler MaterialNProduct Code
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
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VENTANA PD-L1 (SP142) Assay
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- VENTANA MEDICAL SYSTEMS, INC.
- Trade Name
- VENTANA PD-L1 (SP142) Assay
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision Date
- 10/18/2016
- Days to Decision
- 239 days
- Decision Code
- APCB