Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1831338

FEI Number

1831338

Entity Name

ANATECH division of Cancer Diagnostics, Inc.

City/State/Country

Battle Creek, MI, US

Establishment Address

1020 HARTS LAKE RD., Battle Creek, MI 49037, 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

Eosin Y Pureview Eosin Type V Eosin Cryo-Eosin Endure Eosin Dermosin CoverSeal-X, Mounting Media CoverSeal-D, Mounting Media Refrax Mounting Medium CoverSeal-T, Mounting Media CoverSeal-Plus, Mounting Media DPX Mounting Medium Microscope Slides AutoFrost 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 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 Brazilin, 50 gm Amyloid Red, Bulk, kg Alcian Blue, Certified 25 gm Alcian Blue, pH 1, 1 qt Alcian Blue, pH 2.5, 1 qt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HYB	Eosin Y	Hematology	Class 1	864.1850	2010-08-26
LEB	Mounting Media	Pathology	Class 1	864.4010	2016-01-29
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2008-09-22
IGG	Formaldehyde (Formalin, Formol)	Pathology	Class 1	864.4010	2012-10-08
HZC	Mucicarmine	Hematology	Class 1	864.1850	2023-07-24
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2012-10-08
LEF	Stains, Dye Powder	Hematology	Class 1	864.1850	2023-07-24
IDA	Alcian Blue	Hematology	Class 1	864.1850	2018-03-02

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
3007496191	Cancer Diagnostics, Inc.	Durham, NC, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1831338. Last updated year: 2026. Please use registration number 1831338 when referencing this establishment in official correspondence.