Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009432145

FEI Number

2244894

Entity Name

EMD MILLIPORE CORPORATION

City/State/Country

Burlington, MA, US

Establishment Address

400 Summit Drive, Burlington, MA 01803, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MilliporeSigma (Owner Number: 1216103)

Owner / Operator Contact Address

28820 Single Oak Drive, Temecula, CA 92590, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BULK DRY DYE ORANGE METHYL GREEN-PYRONIN (MGP) SOLUTION IODINE GRAM, LUGOLS Declere Permanent Aqueous Mounting Medium HiDef Detection HRP Polymer System UNIVERSAL INDICATOR DAB Substrate Kit Emerald: Antibody Diluent MOLIFEX TISSUE SOFT AEC Substrate Chromagen Protease CytoScan HRP Detection System CytoScan Alk Phos Detection System RINSE SOLUTION NO 2 GRAM,DECOLORIZER 4X5 Peroxide Block CytoScan Alk Phos Detection System w/ Perm Magenta 20X TBS IHC Wash Buffer + Tween20 Permanent Red Chromogen Kit Diamond: Antibody Diluent Avidin-Biotin Blocking Reagents Sodium Thiosulfate Solution HiDef Detection Alk Phos Polymer System Universal Negative Control Serum Background Block 20X PBS IHC Wash Buffer + Tween 20 HEMACOLOR SOLUTION I Trilogy SULFOSALICYLIC ACID Hematoxylin HEMACOLOR SOLUTION II Trilogy Pretreatment Solution HEMACOLOR SOLUTION III Gomori Trichrome CRESYL VIOLET 25GM Saffron Stain MIDAS III-Plus Automated Stainer MIDAS Stainer Formalin Neutral FUCHSIN, Basic Powder MAY GRUNWALD STAIN GIEMSA STAIN 1LT GIEMSA STAIN 500ML GIEMSA STAIN, MODIFIED GIEMSA STAIN 4LT GIEMSA STAIN POWDER 25G HEMACOLOR STAIN SET GRAM STAINING SET 4X EOSIN B SOLUTION TOLUIDINE BLUE O, 25 GRAM IODINE SOLUTION GRAM'S IODINE SOLUTION GRAM IODINE SOLN 4X5 GOLD CHLORIDE SOLUTION HEMATOXYLIN,GILL II HEMATOXYLIN SOLUTION, GILL NO 1 HEMATOXYLIN SOLUTION, GILL NO 2 HEMATOXYLIN,GILL III HEMATOXYLIN SOLUTION, GILL NO 3 HEMATOXYLIN GILL I HEMACOLOR STAIN SET HEMATOXYLIN POWDER EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE EOSIN STAIN 5% SOLN EOSIN Y SOLUTION AQUEOUS EOSIN Y SOLUTION ALCOHOLIC Wright Stain Modified Automated Wright Stain Set MAY-GRUNWALD SOLUTION Wright-Giemsa Stain Modified LEISHMAN STAIN 1L LEISHMAN STAIN 25GM WRIGHT GIEMSA SOLUTION THIAZINE DYE SOLUTION XANTHENE DYE SOLUTION METHYLENE BLUE SOLUTION Methylene Blue, Chloride SAFRANIN STAIN SAFRANIN O SOLUTION ANILINE BLUE W.S. 25 LACTOPHENOL COTTON B LACTOPHENOL 500ML CRYSTAL VIOLET 100GM CRYSTAL VIOLET 25GM CRYSTAL VIOLET SOLUTION CRYSTAL VIOLET 4X500 CRYSTAL VIOLET 200LT CRYSTAL VIOLET POWDER CARBOL FUCHSIN SOLUTION FUCHSIN-CARBOL KINYO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HZH	Orange G	Hematology	Class 1	864.1850	2012-06-28
HZA	Methyl Green	Hematology	Class 1	864.1850	2012-06-28
IAM	Solution, Lugol'S	Pathology	Class 1	864.4010	2012-06-29
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2002-12-02
LEF	Stains, Dye Powder	Hematology	Class 1	864.1850	2012-07-03
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2012-07-03
IGG	Formaldehyde (Formalin, Formol)	Pathology	Class 1	864.4010	2012-06-29
IDF	Acid, Fuchsin	Hematology	Class 1	864.1850	2012-06-29
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2013-08-13
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2002-12-02
ICC	Eosin B	Hematology	Class 1	864.1850	2012-06-29
IAB	Toluidine Blue	Hematology	Class 1	864.1850	2012-06-28
HYI	Iodine, Grams	Hematology	Class 1	864.1850	2012-06-27
HYH	Gold Chloride	Hematology	Class 1	864.1850	2012-06-27
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2012-06-27
HYB	Eosin Y	Hematology	Class 1	864.1850	2012-06-27
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2012-06-28
KFC	Methylene Blue, Tissue Stain	Hematology	Class 1	864.1850	2012-06-29
HZS	Safranin	Hematology	Class 1	864.1850	2012-06-28
KFD	Aniline Blue	Hematology	Class 1	864.1850	2012-06-29
ICF	Crystal Violet For Histology	Hematology	Class 1	864.1850	2012-06-29
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	2012-06-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MilliporeSigma

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9610805	MILLIPORE (UK) LTD	LIVINGSTON, W. LOTHIAN West Lothian, GB
3017212430	CELL MARQUE CORP.	Saint Louis, MO, US
1937990	SIGMA-ALDRICH MANUFACTURING, LLC-H&H	Saint Louis, MO, US
8020892	Merck Millipore Ltd.	COUNTY CORK Munster, IE
1000138378	SIGMA-ALDRICH CORP.	Saint Louis, MO, US

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009432145. Last updated year: 2026. Please use registration number 3009432145 when referencing this establishment in official correspondence.