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
- [email protected]
- Phone
- 415 8710682
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fixative, Alcohol Containing | LDZ | Class 1 | Pathology | No | 2024-04-29 |
| Solution, Decalcifier, Acid Containing | KDX | Class 1 | Pathology | No | 2024-04-29 |
| Wright'S Stain | IAF | Class 1 | Hematology | No | 2024-04-29 |
| Hematoxylin Mayer'S | HYL | Class 1 | Hematology | No | 2024-04-29 |
| Sprays, Synthetic, Smear | IFI | Class 1 | Pathology | No | 2024-04-29 |
| Hematoxylin | HYJ | Class 1 | Hematology | No | 2024-04-29 |
| Device, Decalcifier, Electrolytic | KDZ | Class 1 | Pathology | No | 2024-04-29 |
| Stains, Microbiologic | JTS | Class 1 | Hematology | No | 2024-04-30 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2024-04-29 |
| Stains, Hematology | KQC | Class 1 | Hematology | No | 2024-04-30 |
| Stain, Trichrome, Mallory'S | HYW | Class 1 | Hematology | No | 2024-04-29 |
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 2024-04-29 |
| Safranin | HZS | Class 1 | Hematology | No | 2024-04-29 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2024-04-29 |
| Fluid, Bouin'S | IGN | Class 1 | Pathology | No | 2024-04-29 |
| Solution, Lugol'S | IAM | Class 1 | Pathology | No | 2024-04-29 |
| Reagent, Schiff | HZT | Class 1 | Hematology | No | 2024-04-29 |
| Agent, Clearing | KEM | Class 1 | Pathology | No | 2024-04-29 |
| Solution, Formalin-Alcohol-Acetic Acid | IGF | Class 1 | Pathology | No | 2024-04-29 |
| Phloxine B | HZL | Class 1 | Hematology | No | 2024-04-29 |
| Crystal Violet For Histology | ICF | Class 1 | Hematology | No | 2024-04-29 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2024-04-29 |
| Romanowsky Stains | GJL | Class 1 | Hematology | No | 2026-06-02 |
| Stain, Papanicolau | HZJ | Class 1 | Hematology | No | 2024-04-29 |
| Giemsa Stain | HYF | Class 1 | Hematology | No | 2024-04-29 |
| Eosin Y | HYB | Class 1 | Hematology | No | 2024-04-29 |
| Formaldehyde (Formalin, Formol) | IGG | Class 1 | Pathology | No | 2024-04-29 |
| Mucicarmine | HZC | Class 1 | Hematology | No | 2024-04-29 |
| Fixative, Metallic Containing | LDX | Class 1 | Pathology | No | 2024-04-29 |
| Acid, Periodic | KKS | Class 1 | Hematology | No | 2024-04-29 |
| Hematoxylin Harris'S | HYK | Class 1 | Hematology | No | 2024-04-29 |
| Calibrator, Surrogate | JIW | Class 2 | Clinical Chemistry | No | 2024-04-30 |
| Fixative, Acid Containing | LDW | Class 1 | Pathology | No | 2024-04-29 |
| Hematoxylin, Iron, Weigert'S | IAE | Class 1 | Hematology | No | 2024-04-29 |
| Stains, Chemical Solution | LED | Class 1 | Hematology | No | 2024-04-29 |
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