SIGMA-ALDRICH MANUFACTURING, LLC-H&H

FDA Device Registration & Listing · Saint Louis, MO, US · Registration 1937990

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
1937990
FEI Number
1937990
Entity Name
SIGMA-ALDRICH MANUFACTURING, LLC-H&H
City/State/Country
Saint Louis, MO, US
Establishment Address
3300 SOUTH 2ND ST., Saint Louis, MO 63118, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MilliporeSigma (Owner Number: 1216103)
Owner / Operator Contact Address
28820 Single Oak Drive, Temecula, CA 92590, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TRICHROME STAIN AB SOLUTION TRICHROME STAIN LG SOLUTION MUCICARMINE STOCK SOLUTION TRIZMAL 6.3™ BUFFER CONCENTRATE BUFFER PHOSPHATE PH 7 CITRATE CONCENTRATE PHOSPHATE BUFFER SCOTT'S TAP WATER SUBSTITUTE CONCENTRATE CITRATE SOLUTION CITRATE PHOSPHATE BUFFER CONCENTRATE BUFFER PHOSPHATE PH 6 CITRATE CONCENTRATED SOLUTION TRIZMAL™ CONCENTRATE SAFRANIN STAIN SAFRANIN O SOLUTION NAPHTHOL AS-BI PHOSPHORIC ACID SOLUTION -NAPHTHYL BUTYRATE ESTERASE, KIT. PART 1 TARTRATE SOLUTION LEUKOCYTE ALKALINE PHOSPHATASE (TRAP) KIT ACID PHOSPHATASE KIT, PART 1 FAST GARNET GBC BASE SOLUTION FAST GARNET GBC SALT ACETATE SOLUTION Fontana-Masson Kit SUDAN BLACK B Weigerts Iron Hematoxylin Solution Part A Weigerts Iron Hematoxylin Set Weigerts Iron Hematoxylin Solution Part B SILVER STAIN (MODIFIED GMS) KIT TARTRAZINE SOLUTION VAN GIESON SOLUTION ELASTIC STAIN SAFRANIN O SOLUTION RETICULUM STAIN KIT TRICHROME STAIN (MASSON) KIT GRAM STAIN KIT FOR FILMS PHOSPHOMOLYBDIC ACID SOLUTION PHOSPHOTUNSTIC ACID SOLUTION SILVER STAIN, MODIFIED STEINER-STEINER BIEBRICHS SCARLET ACID FUCHSIN SOLUTION HYDROQUINONE TABLETS ANILINE BLUE SOLUTION FERRIC AMMONIUM SULFATE SOLUTION POTASSIUM PERMANGANATE SOLUTION HEMATOXYLIN SOLUTION, ALCOHOLIC FERRIC CHLORIDE SOLUTION GRAM STAIN KIT FOR TISSUES SODIUM HYDROXIDE SOLUTION OXALIC ACID SOLUTION BORAX SOLUTION WEIGERT'S IODINE SOLUTION ACID HEMATOXYLIN SOLUTION FAST RED VIOLET LB BASE LEUKOCYTE ?-NAPHTHYL ACETATE (NON-SPECIFIC ESTERASE) KIT LEUKOCYTE NAPHTHOL AS-D CHLOROACETATE (SPECIFIC ESTERASE) KIT PARAROSANILINE SOLUTION -NAPHTHYL ACETATE A-NAPHTHYL ACETATE SOLUTION NAPHTHOL AS-D CHLOROACETATE SODIUM NITRITE SOLUTION SODIUM FLUORIDE SOLUTION -NAPHTHYL BUTYRATE SOLUTION FAST BLUE RR SALT FAST CORINTH V SALT DIMETHYL FORMAMIDE FAST BLUE BB BASE SOLUTION ETHYLENE GLYCOL MONOMETHYL ETHER TRIZMAL™ 7.6 BUFFER CONCENTRATE NAPHTHOL AS-D CHLOROACETATE SOLUTION EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE EOSIN STAIN 5% SOLN EOSIN Y SOLUTION AQUEOUS EOSIN Y SOLUTION ALCOHOLIC PAPANICOLAOU STAIN OG 6 PAPANICOLAOU EA-36 1 PAPANICOLAOU STAIN EA 50 PAPANICOLAOU STAIN, MODIFIED EA 65 PAPANICOLAOU EA-50 4 PAPANICOLAOU STAIN EA 65 PAPANICOLAOU OG-6 1 PAPANICOLAOU EA-50 1 PAPANICOLAOU OG-6 10 PAPANICOLAOU OG-6 4 PAPANICOLAOU EA-36 4 EA SOLUTION GILL 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 GLUTARALDEHYDE FBB-ALKALINE SOLUTION FRV-ALKALINE SOLUTION NAPHTHOL AS-BI ALKALINE SOLUTION NAPHTHOL AS-MX PHOSPHATE ALKALINE SOLUTION, 0.25% LEUKOCYTE ALKALINE PHOSPHATASE NUCLEAR FAST RED 5GM NUCLEAR FAST RED SOLUTION GOLD CHLORIDE SOLUTION METHYLENE BLUE SOLUTION Methylene Blue, Chloride SODIUM CHLORIDE SOLUTION CONGO RED SOLUTION SODIUM HYDROXIDE SOLUTION 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 GRAM IODINE SOLUTION GRAM'S IODINE SOLUTION GRAM IODINE SOLN 4X5 METHYL GREEN-PYRONIN (MGP) SOLUTION CARBOL FUCHSIN SOLUTION FUCHSIN-CARBOL KINYO PERIODIC ACID SOLUTION SCHIFFS REAGENT PERIODIC ACID-SCHIFF (PAS) STAINING SYSTEM Mayers Hematoxylin Solution PEROXIDASE INDICATOR REAGENT LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT DIAMINOBENZIDINE GILL MODIFIED EA SOLUTION TRIZMA® CONCENTRATE COPPER NITRATE NEUTRAL RED SOLUTION, BUFFERED MALACHITE GREEN OXLT MALACHITE GREEN SOLUTION HARRIS HEMATOXYLIN SOLUTION, MODIFIED MAY GRUNWALD STAIN GIEMSA STAIN 1LT GIEMSA STAIN 500ML GIEMSA STAIN, MODIFIED GIEMSA STAIN 4LT GIEMSA STAIN POWDER 25G SILVER NITRATE SOLUTION

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HYW Stain, Trichrome, Mallory'S Hematology Class 1 864.1850 2016-01-21
HZC Mucicarmine Hematology Class 1 864.1850 2016-01-21
JCC Ph Buffer Pathology Class 1 864.4010 2012-06-29
HZS Safranin Hematology Class 1 864.1850 2012-06-28
JCI Acid Phosphatase, Cytochemical Hematology Class 1 864.1850 2016-01-21
HYE Solution, Fontanna Silver Hematology Class 1 864.1850 2017-04-21
HZZ Sudan Black B Hematology Class 1 864.1850 2012-06-28
IAE Hematoxylin, Iron, Weigert'S Hematology Class 1 864.1850 2016-01-21
LEE Stains, Dye Solution Hematology Class 1 864.1850 2016-01-21
HZM Hematoxylin, Acid, Phosphotungstic Hematology Class 1 864.1850 2016-01-21
JCH Esterase Hematology Class 1 864.1850 2016-01-21
HYB Eosin Y Hematology Class 1 864.1850 2012-06-27
HZJ Stain, Papanicolau Hematology Class 1 864.1850 2012-06-28
HYJ Hematoxylin Hematology Class 1 864.1850 2012-06-27
IFT Glutaraldehyde Pathology Class 1 864.4010 2016-01-21
JCJ Alkaline Phosphatase Hematology Class 1 864.7660 2016-01-21
HZF Nuclear Fast Red Hematology Class 1 864.1850 2012-06-28
HYH Gold Chloride Hematology Class 1 864.1850 2012-06-27
KFC Methylene Blue, Tissue Stain Hematology Class 1 864.1850 2012-06-29
ICH Congo Red Hematology Class 1 864.1850 2012-06-29
PPM General Purpose Reagent Pathology Class 1 864.4010 2002-12-02
HYI Iodine, Grams Hematology Class 1 864.1850 2012-06-27
HZA Methyl Green Hematology Class 1 864.1850 2012-06-28
ICL Carbol Fuchsin Hematology Class 1 864.1850 2012-06-29
KKS Acid, Periodic Hematology Class 1 864.1850 2016-01-21
HYL Hematoxylin Mayer'S Hematology Class 1 864.1850 2016-01-12
GIA Test, Leukocyte Peroxidase Hematology Class 1 864.7675 2016-01-21
KFE Neutral Red Hematology Class 1 864.1850 2012-06-29
KJY Malachite Green Hematology Class 1 864.1850 2012-07-03
HYK Hematoxylin Harris'S Hematology Class 1 864.1850 2012-06-28
HYF Giemsa Stain Hematology Class 1 864.1850 2013-08-13
HZX Silver Nitrate Hematology Class 1 864.1850 2025-01-09

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
8020892 Merck Millipore Ltd. COUNTY CORK Munster, IE
1000138378 SIGMA-ALDRICH CORP. Saint Louis, MO, US
3009432145 EMD MILLIPORE CORPORATION Burlington, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843684 Sigma Chemical Co. SIGMA SUDAN BLACK REAGENT 380-1 1984-10-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1937990. Last updated year: 2026. Please use registration number 1937990 when referencing this establishment in official correspondence.
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