FDA Registration
Active
🇺🇸 United States
ANATECH division of Cancer Diagnostics, Inc.
Reg #: 1831338
·
FEI: 1831338
·
Expires 2026
Products
14
Proprietary Names
109
Establishment Types
4
Classifications
14
Registration Details
- Registration Name
- ANATECH division of Cancer Diagnostics, Inc.
- Registration Number
- 1831338
- FEI Number
- 1831338
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1020 HARTS LAKE RD.
- City
- Battle Creek
- State
- MI
- ZIP
- 49037
- Country
- US
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Eosin Y | HYB | Class 1 | Hematology | No | 2010-08-26 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2016-01-29 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2008-09-22 |
| Formaldehyde (Formalin, Formol) | IGG | Class 1 | Pathology | No | 2012-10-08 |
| Mucicarmine | HZC | Class 1 | Hematology | No | 2023-07-24 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2012-10-08 |
| Stains, Dye Powder | LEF | Class 1 | Hematology | No | 2023-07-24 |
| Alcian Blue | IDA | Class 1 | Hematology | No | 2018-03-02 |
| Hematoxylin | HYJ | Class 1 | Hematology | No | 2010-08-26 |
| Hematoxylin Harris'S | HYK | Class 1 | Hematology | No | 2010-08-26 |
| Stains, Chemical Solution | LED | Class 1 | Hematology | No | 2018-03-02 |
| Agent, Clearing | KEM | Class 1 | Pathology | No | 2012-10-08 |
| Stains, Dye Solution | LEE | Class 1 | Hematology | No | 2010-08-26 |
| Fixative, Alcohol Containing | LDZ | Class 1 | Pathology | No | 2012-10-08 |
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
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
Harris Hematoxylin
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
Clearing Agent
Pro-Par Clearant, 1 gal
Pro-Par Clearant, 4 gal case
Pro-Par Clearant, 5 gal
Pro-Par Clearant, 55 gal
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
Prefer Prefills, 90 ml
Prefer, 55 gal
Prefer Prefills, 60 ml
Prefer Prefills, 20 ml
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)