BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cancer Diagnostics, Inc.

    Reg #: 3007496191 · FEI: 3007496191 · Expires 2026
    View on FDA
    Products
    44
    Proprietary Names
    121
    Establishment Types
    3
    Classifications
    44

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    Registration Details

    Registration Name
    Cancer Diagnostics, Inc.
    Registration Number
    3007496191
    FEI Number
    3007496191
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    116 Page Point Circle
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K902591

    Owner / Operator

    Firm Name
    Cancer Diagnostics, Inc.
    Operator Number
    10027057
    Address
    116 Page Point Circle
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US
    Correspondent
    Patrick O'Neill

    Products

    Device Name Product Code
    Formaldehyde (Formalin, Formol) IGG
    Scalpel, One-Piece GDX
    Hematoxylin HYJ
    Fluid, Bouin'S IGN
    Stains, Hematology KQC
    Cassettes, Tissue IDZ
    Products, Red-Cell Lysing Products GGK
    Orange G HZH
    Fixative, Alcohol Containing LDZ
    Stains, Chemical Solution LED
    Spatula, Cervical, Cytological HHT
    Solution, Formalin-Alcohol-Acetic Acid IGF
    Mucicarmine HZC
    Formalin, Neutral Buffered IFP
    Coverslips, Microscope Slide KES
    Acid, Periodic KKS
    Stains, Dye Solution LEE
    Crystal Violet For Histology ICF
    Punch, Surgical LRY
    Agent, Clearing KEM
    Fixative, Acid Containing LDW
    Alcian Blue IDA
    Stains, Dye Powder LEF
    Mounting Media LEB
    Tape, Measuring, Rulers And Calipers FTY
    Blade, Scalpel GES
    Solution, Decalcifier, Acid Containing KDX
    Specimen/Tissue, Identification Orientation MJI
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Curette HTF
    Filters, Cell Collection, Tissue Processing KET
    Hematoxylin Mayer'S HYL
    Formulations, Paraffin, All KEO
    Sprays, Synthetic, Smear IFI
    Media, Mounting, Water Soluble KEQ
    Hematoxylin Harris'S HYK
    Slides, Microscope KEW
    Preservative, Cytological LEA
    Fixative, Formalin-Containing LDY
    Eosin Y HYB
    Container, Embedding KER
    General Purpose Reagent PPM
    Microtome, Accessories IDL
    Reagent, Schiff HZT

    Proprietary Names

    Z-Fix Bulk, LT Z-Fix Prefills, 60 ml Z-Fix Prefills, 90 ml Z-Fix, 1 gal Alcoholic, Z-Fix Concentrate Z-Fix Concentrate, 1 gal Zinc Formalin, 5 gal Zinc Formalin Prefills, 20 ml Zinc Formalin Prefills, 60 ml Z-Fix, 5 gal Zinc Formalin, 1 gal Z-Fix, 55 gal Zinc Formalin, 90 ml Z-5 Zinc Formalin, 55 gal Z-Fix, 4 gal case Z-Fix Prefills, 20 ml Zinc Formalin, 4 gal case Hematoxylin, Certified Gill 1,2,3 Hematoxylin Cyto-Hematoxylin PureView Hematoxylin Affinitiy Hematoxylin Cryo-Hematoxylin Hematoxylin Extra Endure Hematoxylin H1 Plus Hematoxylin IHC Hematoxylin H2 Plus Hematoxylin Hematoxylin Normal Mayer's Hematoxylin Lyse Red Prefer Prefills, 90 ml Prefer, 55 gal Prefer Prefills, 60 ml Prefer Prefills, 20 ml Movat Pentachrome Stain Kit Luxol Fast Blue Stain Kit Picro-Sirius Red Stain Kit Wright Giemsa Stain Kit Warthin-Starry Stain Kit AFB Stain Kit Iron Stain Kit H. Pylori Rapid Stain Kit Oil Red O Stain Kit Reticulum Stain Kit Alcian Blue PAS Stain Kit Copper Stain Kit Trichrome Stain Kit PTAH Stain Kit Fite Stain Kit Colloidal Iron Stain Kit Bielschowsky's Stain Kit Steiner Stain Kit Alcian Blue pH 1 Stain Kit Gram Stain Kit Orcein Stain Kit (Hepatitis B) Elastic Stain Kit Pneumocystis Stain Kit Calcium Stain Kit (Modified Von Kossa) Amyloid Stain Kit (Congo Red) Alcian Blue pH 2.5 Stain Kit Jones Stain Kit Giemsa Stain Kit (May Grunwald) Twort's Counterstain Kit Eosinophil Mast Cell Stain Kit Fontana Masson Stain Kit GMS Stain Kit Perodic Acic Schiff Stain Kit Cytette Snap Tip Formalin Alcohol Acetic Acid Solution EZ Carmine, Bulk, kg EZ Carmine, 25 gm Mucicarmine Stain Kit EZ Mucicarmine, 1 qt CB Formalin, 1 gal CBA Formalin, 1 gal NBF, 5 gal Periodic Acid Hp Blue, 1 qt Amyloid Red Stain, 1 qt Hp Blue, 1 gal Amyloid Stain Kit Hp Yellow, 1 qt Helicobacter Stain Kit Brazilliant, 1 qt Hp Yellow, 1 gal EZ Green, 1 qt Tango Clearing Agent Pro-Par Clearant, 1 gal Pro-Par Clearant, 4 gal case Pro-Par Clearant, 5 gal Pro-Par Clearant, 55 gal Alcian Blue, Certified 25 gm Alcian Blue, pH 1, 1 qt Alcian Blue, pH 2.5, 1 qt Brazilin, 50 gm Amyloid Red, Bulk, kg CoverSeal-X, Mounting Media CoverSeal-D, Mounting Media Refrax Mounting Medium CoverSeal-T, Mounting Media CoverSeal-Plus, Mounting Media DPX Mounting Medium N/A Specimen Containers Ultraffin, Ultraffin e, Ultraffin i, Ultraffin x PureAffin® Paraffins. PureAffin® E, I, X, R53, R56, 1,2, Bloxx™, Blue Cover-Seal™-AQ Ultra-Freeze™ OCT Harris Hematoxylin Microscope Slides AutoFrost ThinLayer Preserve Solution CF2 Eosin Y Pureview Eosin Type V Eosin Cryo-Eosin Endure Eosin Dermosin

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility