CHAPTEC AMERICA

FDA Device Registration & Listing · Montreal Quebec, CA · Registration 3017970519

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017970519
FEI Number
3017970519
Entity Name
CHAPTEC AMERICA
City/State/Country
Montreal Quebec, CA
Establishment Address
470 Laurendeau, Montreal Quebec H1B5M2, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Chaptec America (Owner Number: 10090688)
Owner / Operator Contact Address
470 Laurendeau, Montreal, CA-QC H1B5M2, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

METHANOL USP METHANOL NITRIC ACID (68-70%, A.C.S.Grade) DECAL-PLUS EDTA BASED DECALCIFYING SOLUTION FORMIC ACID (85%, A.C.S. Grade) NITRIC ACID - AQUEOUS SOLUTION 5% V/V CHLORHYDRIC ACID (37%, Reagent grade) WRIGHT STAIN MAYER HEMATOXYLIN MAYER HEMATOXYLIN MODIFIED SP-FIX CYTOLOGY FIXATIVE (PUMP SPRAY) HEMATOXYLIN 2 RAPID GILL 3 HEMATOXYLIN GILL 2 HEMATOXYLIN GILL 1 HEMATOXYLIN HEMATOXYLIN 1 RAPID DECAL-SOFT CD DECALCIFICATION SOLUTION GAIRNS 10% NITRIC ACID DECALCYFYING SOLUTION GOODING & STEWART DECALCYFYING SOLUTION DECAL-FX-1 FIXATION & DECALCIFICATION SOLUTION DECAL-FAST DECALCIFICATION SOLUTION URINE SEDIMENT STAIN (Sternheimer-Malbin) ISOPROPYL ALCOHOL 70% DENATURED ETHYL ALCOHOL ANHYDROUS 100% DENATURED ETHYL ALCOHOL ANHYDROUS 95% DENATURED ETHYL ALCOHOL ANHYDROUS 50% MICHEL TRANSPORT MEDIUM ETHYL ACETATE (EQUAL OR GREATER THAN 99.8%, Liquid, A.C.S. Grade) DENATURED ETHYL ALCOHOL ANHYDROUS 90% DENATURED ETHYL ALCOHOL ANHYDROUS 80% DECALCIFICATION ENDPOINT TESTING KIT ETHYL ETHER ANHYDROUS ACETONE HISTOLOGY GRADE ISOPROPYL ALCOHOL 99% ETHYL ACETATE ( HPLC Grade) DENATURED ETHYL ALCOHOL ANHYDROUS 70% ACETONE MINIMUM 99,5 ACS GRADE WRIGHT & GIEMSA STAIN MAY-GRUNWALD STAIN PHLOXINE TRICHROMIC COUNTERSTAIN PHLOXINE 2% TRICHROMIC COUNTERSTAIN BUFFERED ISOTONIC SALINE SOLUTION (0.85%, PH; 7-7.2 ) NON STERILE BUFFERED BLOOD BANK SALINE SOLUTION (PH; 7-7.2 ) ISOTONIC SALINE SOLUTION (0,9%) NON STERILE SAFRANINE O GRAM COUNTERSTAIN SAFRAN COUNTERSTAIN NEUTRAL BUFFERED FORMALDEHYDE 20% FORMALIN, CONCENTRATED 1:5 (NEUTRAL BUFFERED) TISSUFIX NEUTRAL BUFFERED FORMALDEHYDE 10% BOUIN FIXATIVE LUGOL IODINE STAINING SOLUTION SCHIFF REAGENT XYLENE HYDROGEN PEROXIDE (6% W/W, Liquid, ACS Grade) GRAM DECOLORIZER 50% ACETONE / 50% ALCOHOL HYDROGEN PEROXIDE (3% W/W, Liquid, ACS Grade) GRAM DECOLORIZER 25% ACETONE / 75% ALCOHOL ALCOHOL - ACID DECOLORIZER 1% HYDROGEN PEROXIDE (3O% W/W, Liquid, ACS Grade) TOLUENE GRAM DECOLORIZER 25% ACETONE / 75% ISOPROPYL ALCOHOL HEXANE (A.C.S. Grade EQUAL OR GREATER THAN 98.5%) ALCOHOL - ACID DECOLORIZER 0,25% ALCOHOL - ACID DECOLORIZER 0,5% FIXATIVE AFA (ALCOHOL, FORMALDEHYDE, ACETIC ACID ) PHLOXINE B (AQUEOUS SOLUTION 2% W/V) PHLOXINE B (AQUEOUS SOLUTION 1% W/V) PHLOXINE B 0,25% W/V, modified (Buffered, pH 5,10 ± 0,05) CRYSTAL VIOLET (AMMONIUM OXALATE), FOR GRAM STAIN CRYSTAL VIOLET (CARBOLIC), FOR GRAM STAIN CRYSTAL VIOLET FOR GRAM STAIN PH BUFFER 4,01 PHOSPHATE BUFFER, CONCENTRATED, MAKES 4 L, pH 6,8 PBS BUFFER READY TO USE PBS BUFFER WRIGHT STAIN BUFFER PH BUFFER 101 SORENSEN BUFFER PH 7 SORENSEN BUFFER PH 7.2 MICHEL WASH SOLUTION PBS BUFFER - CONCENTRATED, MAKES 4L (pH 7,2 ± 0,2) PHOSPATE BUFFER, READY TO USE, Ph 6,8 SORENSEN BUFFER PH 6.8 Hemachromie PAP STAIN EA50 PAP STAIN OG6 PAP STAIN EA65 GIEMSA STAIN GIEMSA STAIN, MODIFIED Eosin Y (alcoholic acidified 0,5% W/V) Eosin Y (alcoholic 0.5% W/V) EOSIN Y, WITH PHLOXIN B ALCOHOLIC EOSIN Y, WITH PHLOXIN B (AQUEOUS, Eosin Y 0,1%, Phloxin B 0,1%) Eosin Y (aqueous 0,5% W/V) FORMALDEHYDE 37% MUCICARMIN, STOCK SOLUTION

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LDZ Fixative, Alcohol Containing Pathology Class 1 864.4010 2024-04-29
KDX Solution, Decalcifier, Acid Containing Pathology Class 1 864.4010 2024-04-29
IAF Wright'S Stain Hematology Class 1 864.1850 2024-04-29
HYL Hematoxylin Mayer'S Hematology Class 1 864.1850 2024-04-29
IFI Sprays, Synthetic, Smear Pathology Class 1 864.4010 2024-04-29
HYJ Hematoxylin Hematology Class 1 864.1850 2024-04-29
KDZ Device, Decalcifier, Electrolytic Pathology Class 1 864.3010 2024-04-29
JTS Stains, Microbiologic Hematology Class 1 864.1850 2024-04-30
PPM General Purpose Reagent Pathology Class 1 864.4010 2024-04-29
KQC Stains, Hematology Hematology Class 1 864.1850 2024-04-30
HYW Stain, Trichrome, Mallory'S Hematology Class 1 864.1850 2024-04-29
JCE Solution, Isotonic Pathology Class 1 864.4010 2024-04-29
HZS Safranin Hematology Class 1 864.1850 2024-04-29
IFP Formalin, Neutral Buffered Pathology Class 1 864.4010 2024-04-29
IGN Fluid, Bouin'S Pathology Class 1 864.4010 2024-04-29
IAM Solution, Lugol'S Pathology Class 1 864.4010 2024-04-29
HZT Reagent, Schiff Hematology Class 1 864.1850 2024-04-29
KEM Agent, Clearing Pathology Class 1 864.4010 2024-04-29
IGF Solution, Formalin-Alcohol-Acetic Acid Pathology Class 1 864.4010 2024-04-29
HZL Phloxine B Hematology Class 1 864.1850 2024-04-29
ICF Crystal Violet For Histology Hematology Class 1 864.1850 2024-04-29
JCC Ph Buffer Pathology Class 1 864.4010 2024-04-29
GJL Romanowsky Stains Hematology Class 1 864.1850 2026-06-02
HZJ Stain, Papanicolau Hematology Class 1 864.1850 2024-04-29
HYF Giemsa Stain Hematology Class 1 864.1850 2024-04-29
HYB Eosin Y Hematology Class 1 864.1850 2024-04-29
IGG Formaldehyde (Formalin, Formol) Pathology Class 1 864.4010 2024-04-29
HZC Mucicarmine Hematology Class 1 864.1850 2024-04-29

Official Correspondent

Jean Boily

US Agent Details

James Flynn Business: Primority Ltd Email: jf@primority.com Phone: (415) 8710682

Related Public Records

Same Entity

Chaptec America
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
K761138 Zeus Scientific, Inc. FA TISSUE FIXATIVE & WASH SET 1978-01-06
K842913 E K Ind., Inc. WRIGHT STAIN FIXATIVE 1984-09-07
K821443 Lerner Laboratories, Inc. FORMICAL 1982-06-02
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

Registration Number Establishment Name Location
3003887639 DIAMOND WIPES INTERNATIONAL, INC. Chino, CA, US
3010420046 CITOTEST Labware Manufacturing CO., LTD. Haimen Jiangsu, CN
3004421347 LGM INTERNATIONAL INC. Melbourne, FL, US
3033524192 Noul Co., Ltd. Yongin Si Gyeonggi, KR
3002805583 VOLUSOL Tooele, UT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017970519. Last updated year: 2026. Please use registration number 3017970519 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.