Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2247035

FEI Number

1000122268

Entity Name

Ethos Biosciences, INC.

City/State/Country

Logan Township, NJ, US

Establishment Address

2070 Center Square Road, Logan Township, NJ 08085, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Ethos Biosciences (Owner Number: 10048233)

Owner / Operator Contact Address

2070 Center Square Road, Logan Township, NJ 08085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics Ethos Biosciences formerly known as Astral Diagnostics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IGG	Formaldehyde (Formalin, Formol)	Pathology	Class 1	864.4010	2026-03-06
IAM	Solution, Lugol'S	Pathology	Class 1	864.4010	2022-10-11
GJL	Romanowsky Stains	Hematology	Class 1	864.1850	2014-12-19
HYO	Hematoxylin Weigert'S	Hematology	Class 1	864.1850	2025-04-11
HYW	Stain, Trichrome, Mallory'S	Hematology	Class 1	864.1850	2025-04-07
HYS	Light Green	Hematology	Class 1	864.1850	2025-05-07
KDX	Solution, Decalcifier, Acid Containing	Pathology	Class 1	864.4010	2026-03-27
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2022-10-11
ICN	Biebrich Scarlet	Hematology	Class 1	864.1850	2025-04-14
JSY	Kit, Identification, Mycobacteria	Microbiology	Class 1	866.2660	2025-06-11
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2022-10-11
KKW	Basic Fuchsin	Hematology	Class 1	864.1850	2022-10-11
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	2022-10-11
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2025-06-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-10-11
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2026-06-06
KJO	Brilliant Green	Hematology	Class 1	864.1850	2022-10-11
KJX	Jenner Stain	Hematology	Class 1	864.1850	2026-06-05
KFD	Aniline Blue	Hematology	Class 1	864.1850	2022-10-11
ICG	Cresyl Violet Acetate	Hematology	Class 1	864.1850	2022-10-11
IAC	Van Gieson'S Stain	Hematology	Class 1	864.1850	2026-06-11
KJY	Malachite Green	Hematology	Class 1	864.1850	2022-10-11
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2022-10-11
LDY	Fixative, Formalin-Containing	Pathology	Class 1	864.4010	2025-12-02
HZF	Nuclear Fast Red	Hematology	Class 1	864.1850	2022-10-11
KFC	Methylene Blue, Tissue Stain	Hematology	Class 1	864.1850	2022-10-11
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2022-10-11
ICF	Crystal Violet For Histology	Hematology	Class 1	864.1850	2022-10-11
HZX	Silver Nitrate	Hematology	Class 1	864.1850	2025-04-30
HZT	Reagent, Schiff	Hematology	Class 1	864.1850	2022-10-11
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2022-10-11
IDA	Alcian Blue	Hematology	Class 1	864.1850	2022-10-11
LEB	Mounting Media	Pathology	Class 1	864.4010	2022-10-11
HYB	Eosin Y	Hematology	Class 1	864.1850	2022-10-11
KKS	Acid, Periodic	Hematology	Class 1	864.1850	2025-04-28
HZJ	Stain, Papanicolau	Hematology	Class 1	864.1850	2022-10-11
HYC	Fast Green	Hematology	Class 1	864.1850	2022-10-11
HYI	Iodine, Grams	Hematology	Class 1	864.1850	2022-10-11
KJK	Auramine O	Hematology	Class 1	864.1850	2025-04-07
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2026-04-07
HZS	Safranin	Hematology	Class 1	864.1850	2022-10-11
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2025-04-25
LEF	Stains, Dye Powder	Hematology	Class 1	864.1850	2022-10-11
HYK	Hematoxylin Harris'S	Hematology	Class 1	864.1850	2022-10-11

Official Correspondent

Cinnamon Tinsley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ethos Biosciences

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K821443	Lerner Laboratories, Inc.	FORMICAL	1982-06-02
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07

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-0025-05	Becton Dickinson & Co.	1	Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0012-2015	Richard-Allan Scientific Company	1	Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0013-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0014-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2247035. Last updated year: 2026. Please use registration number 2247035 when referencing this establishment in official correspondence.