FDA Registration Active 🇺🇸 United States

SIGMA-ALDRICH MANUFACTURING, LLC

Reg #: 1938173 · FEI: 1938173 · Expires 2026
Products
19
Proprietary Names
126
Establishment Types
3
Classifications
19

Registration Details

Registration Name
SIGMA-ALDRICH MANUFACTURING, LLC
Registration Number
1938173
FEI Number
1938173
Status
Active
Expiry Year
2026
Initial Importer
No
Address
545 SOUTH EWING AVE.
City
ST. LOUIS
State
MO
ZIP
63103
Country
US

Regulatory Submissions

510(k) Number
K103502

Owner / Operator

Firm Name
MilliporeSigma
Operator Number
1216103
Address
28820 Single Oak Drive
City
Temecula
State
CA
Postal Code
92590
Country
US

Products

Device Name Product Code
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection PHP
Acid Phosphatase, Cytochemical JCI
Acid, Periodic KKS
Congo Red ICH
Wright'S Stain IAF
Ph Buffer JCC
Alkaline Phosphatase JCJ
Stain, Fetal Hemoglobin GHQ
System, Immunomagnetic, Circulating Cancer Cell, Enumeration NQI
Iron Stains GGH
Control Material, Blood Circulating Epithelial Cancer Cell NRS
Methenamine Silver HYZ
General Purpose Reagent PPM
Solution, Fontanna Silver HYE
Esterase JCH
Stains, Dye Solution LEE
Hematoxylin, Iron, Weigert'S IAE
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection SBB
Test, Leukocyte Peroxidase GIA

Proprietary Names

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 PERIODIC ACID SOLUTION SCHIFFS REAGENT PERIODIC ACID-SCHIFF (PAS) STAINING SYSTEM SODIUM CHLORIDE SOLUTION CONGO RED SOLUTION SODIUM HYDROXIDE SOLUTION 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 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 FBB-ALKALINE SOLUTION FRV-ALKALINE SOLUTION NAPHTHOL AS-BI ALKALINE SOLUTION NAPHTHOL AS-MX PHOSPHATE ALKALINE SOLUTION, 0.25% LEUKOCYTE ALKALINE PHOSPHATASE Fetal Hemoglobin Kit CELLSEARCH Circulating Tumor Cell Kit (Epithelial) IRON STAIN POTASSIUM FERROCYANIDE SOLUTION PARAROSANILINE SOLUTION HYDROCHLORIC ACID SOLUTION CellSearch Epithelial Control Cell METHENAMINE SILVER 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 Fontana-Masson Kit FAST RED VIOLET LB BASE LEUKOCYTE ?-NAPHTHYL ACETATE (NON-SPECIFIC ESTERASE) KIT LEUKOCYTE NAPHTHOL AS-D CHLOROACETATE (SPECIFIC ESTERASE) KIT -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 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 OXALIC ACID SOLUTION BORAX SOLUTION WEIGERT'S IODINE SOLUTION Weigerts Iron Hematoxylin Solution Part A Weigerts Iron Hematoxylin Set Weigerts Iron Hematoxylin Solution Part B PEROXIDASE INDICATOR REAGENT LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT DIAMINOBENZIDINE GILL MODIFIED EA SOLUTION TRIZMA® CONCENTRATE COPPER NITRATE

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Manufacture Medical Device