Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518071

FEI Number

2518071

Entity Name

POLYSCIENCES, INC.

City/State/Country

WARRINGTON, PA, US

Establishment Address

400 VALLEY RD., WARRINGTON, PA 18976, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

POLYSCIENCES, INC. (Owner Number: 2518071)

Owner / Operator Contact Address

400 VALLEY RD., --, Warrington, PA 18976, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PEEL-A-WAY AND PARA FUNGI-FLUOR KIT FOR GE Tissue-Guard Coverslipping Film EOSIN Y EOSIN Y ALCHOLIC SOLUTION MULTIPLE STAIN SOLUTION ACID-FAST BACTISTAIN KIT PolyFin Paraffin Gem Cut Paraffin Peel-A-Way Micro Cut Paraffin WRIGHT STAIN CERTIFIED WRIGHT STAIN SOLUTION TruColor Wright Giemsa Stain Kit TruColor May Grunwald Stain Kit TruColor wright Stain Kit TruColor Wright Buffer Kit TruColor Giemsa Stain Kit TruColor Wright Giemsa Stain TruColor Wright Stain TruColor Wright Giemsa Buffer Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KER	Container, Embedding	Pathology	Class 1	864.3010	2003-04-18
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	1994-05-17
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2013-11-08
HYB	Eosin Y	Hematology	Class 1	864.1850	1992-08-13
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	1995-09-26
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	1995-09-26
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	1992-08-13
IAF	Wright'S Stain	Hematology	Class 1	864.1850	1992-08-13
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2012-12-03

Official Correspondent

Viviana Leon-Morales

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

POLYSCIENCES, INC.

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
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-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.

Similar Registrations

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3007480628	Jiangsu Huida Medical Instruments Co., Ltd	Yancheng Jiangsu, CN
3003701178	SIAM INTERMAGNATE CO., LTD.	BANGKOK Krung Thep Maha Nakhon, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518071. Last updated year: 2026. Please use registration number 2518071 when referencing this establishment in official correspondence.