FDA Registration Active 🇨🇦 Canada

CHAPTEC AMERICA

Reg #: 3017970519 · FEI: 3017970519 · Expires 2026
Products
35
Proprietary Names
120
Establishment Types
2
Classifications
35

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Registration Details

Registration Name
CHAPTEC AMERICA
Registration Number
3017970519
FEI Number
3017970519
Status
Active
Expiry Year
2026
Initial Importer
No
Address
470 Laurendeau
City
Montreal Quebec
Country
CA

Owner / Operator

Firm Name
Chaptec America
Operator Number
10090688
Address
470 Laurendeau
City
Montreal
State
Quebec
Postal Code
H1B5M2
Country
CA
Correspondent
Jean Boily

US Agent

Business Name
Primority Ltd
Contact Name
James Flynn
Address
9160 Forum Corporate Pkwy Ste 350
City
Fort Myers
State
FL
ZIP
33905
Country
US
Phone
415 8710682

Products

Device Name Product Code
Fixative, Alcohol Containing LDZ
Solution, Decalcifier, Acid Containing KDX
Wright'S Stain IAF
Hematoxylin Mayer'S HYL
Sprays, Synthetic, Smear IFI
Hematoxylin HYJ
Device, Decalcifier, Electrolytic KDZ
Stains, Microbiologic JTS
General Purpose Reagent PPM
Stains, Hematology KQC
Stain, Trichrome, Mallory'S HYW
Solution, Isotonic JCE
Safranin HZS
Formalin, Neutral Buffered IFP
Fluid, Bouin'S IGN
Solution, Lugol'S IAM
Reagent, Schiff HZT
Agent, Clearing KEM
Solution, Formalin-Alcohol-Acetic Acid IGF
Phloxine B HZL
Crystal Violet For Histology ICF
Ph Buffer JCC
Romanowsky Stains GJL
Stain, Papanicolau HZJ
Giemsa Stain HYF
Eosin Y HYB
Formaldehyde (Formalin, Formol) IGG
Mucicarmine HZC
Fixative, Metallic Containing LDX
Acid, Periodic KKS
Hematoxylin Harris'S HYK
Calibrator, Surrogate JIW
Fixative, Acid Containing LDW
Hematoxylin, Iron, Weigert'S IAE
Stains, Chemical Solution LED

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 AZF FIXATIVE (ACID - ZINC - FORMALIN) HOLLAND FIXATIVE HOLLAND FIXATIVE, MODIFIED 1% W/V PERIODIC ACID AQUEOUS SOLUTION HARRIS HEMATOXYLIN ,MERCURY FREE HARRIS HEMATOXYLIN ,MERCURY FREE WITH ACETIC ACID HARRIS HEMATOXYLIN MODIFIED,MERCURY FREE PROCESS RECORD SLIDE-CALIBRATOR PICRIC ACID SATURATED AQUEOUS SOLUTION PICRIC ACID (ALCOHOLIC SOLUTION 2.5% P/V) PICRIC ACID AQUEOUS SOLUTION 1.2% W/V ACETIC ACID (Glacial, A.C.S. grade) B-FIX ( B-5 FIXATIVE SUBSTITUTE MERCURY FREE) WEIGERT FERRIC HEMATOXYLIN, SOLUTION A WEIGERT FERRIC HEMATOXYLIN, SOLUTION B BX10 BLUEING REAGENT SCOTT WATER SUBSTITUTE - 10 X CONCENTRATE AQ-X20 DIFFERENTIATING SOLUTION FOR H&E SCOTT WATER SUBSTITUTE - READY TO USE SCOTT WATER SUBSTITUTE - CONCENTRATED MAKES 1L SODIUM HYDROXIDE (40% W/W, REAGENT GRADE) DIFFERENTIATING SOLUTION ALCOHOL- ACID-1% SODIUM HYDROXIDE (0,1N, Liquid, Reagent grade)

Establishment Types

Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device