Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007496191

FEI Number

3007496191

Entity Name

Cancer Diagnostics, Inc.

City/State/Country

Durham, NC, US

Establishment Address

116 Page Point Circle, Durham, NC 27703, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cancer Diagnostics, Inc. (Owner Number: 10027057)

Owner / Operator Contact Address

116 Page Point Circle, Durham, NC 27703, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IGG	Formaldehyde (Formalin, Formol)	Pathology	Class 1	864.4010	2012-10-08
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2010-08-26
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2010-08-26
IGN	Fluid, Bouin'S	Pathology	Class 1	864.4010	2018-03-02
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2018-03-02
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2012-10-08
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2026-03-05
HZH	Orange G	Hematology	Class 1	864.1850	2010-08-26
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2012-10-08
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2018-03-02
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2013-01-25
IGF	Solution, Formalin-Alcohol-Acetic Acid	Pathology	Class 1	864.4010	2010-08-28
HZC	Mucicarmine	Hematology	Class 1	864.1850	2023-07-24
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2012-10-08
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2012-10-08
KKS	Acid, Periodic	Hematology	Class 1	864.1850	2021-11-22
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2010-08-26
ICF	Crystal Violet For Histology	Hematology	Class 1	864.1850	2018-03-02
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-03-26
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2012-10-08
LDW	Fixative, Acid Containing	Pathology	Class 1	864.4010	2018-04-10
IDA	Alcian Blue	Hematology	Class 1	864.1850	2018-03-02
LEF	Stains, Dye Powder	Hematology	Class 1	864.1850	2023-07-24
LEB	Mounting Media	Pathology	Class 1	864.4010	2016-01-29
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2014-09-25
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2010-08-26
KDX	Solution, Decalcifier, Acid Containing	Pathology	Class 1	864.4010	2012-10-08
MJI	Specimen/Tissue, Identification Orientation	Pathology	Class 1	864.3010	2017-12-28
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2014-09-17
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2020-03-26
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2018-03-02
HYL	Hematoxylin Mayer'S	Hematology	Class 1	864.1850	2012-10-08
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2010-08-26
IFI	Sprays, Synthetic, Smear	Pathology	Class 1	864.4010	2014-09-25
KEQ	Media, Mounting, Water Soluble	Pathology	Class 1	864.4010	2010-08-26
HYK	Hematoxylin Harris'S	Hematology	Class 1	864.1850	2010-08-26

Official Correspondent

Patrick O'Neill

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cancer Diagnostics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1831338	ANATECH division of Cancer Diagnostics, Inc.	Battle Creek, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09
K821443	Lerner Laboratories, Inc.	FORMICAL	1982-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2012	EMD Chemicals Inc.	1	Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007496191. Last updated year: 2026. Please use registration number 3007496191 when referencing this establishment in official correspondence.