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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | PHP | Class 3 | Unknown | No | 2024-11-19 |
| Acid Phosphatase, Cytochemical | JCI | Class 1 | Hematology | No | 2016-01-21 |
| Acid, Periodic | KKS | Class 1 | Hematology | No | 2016-01-21 |
| Congo Red | ICH | Class 1 | Hematology | No | 2012-06-29 |
| Wright'S Stain | IAF | Class 1 | Hematology | No | 2012-06-28 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2012-06-29 |
| Alkaline Phosphatase | JCJ | Class 1 | Hematology | No | 2016-01-21 |
| Stain, Fetal Hemoglobin | GHQ | Class 2 | Hematology | No | 2016-01-28 |
| System, Immunomagnetic, Circulating Cancer Cell, Enumeration | NQI | Class 2 | Immunology | No | 2016-01-28 |
| Iron Stains | GGH | Class 1 | Hematology | No | 2016-01-21 |
| Control Material, Blood Circulating Epithelial Cancer Cell | NRS | Class 2 | Hematology | No | 2016-01-28 |
| Methenamine Silver | HYZ | Class 1 | Hematology | No | 2012-06-28 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2002-12-02 |
| Solution, Fontanna Silver | HYE | Class 1 | Hematology | No | 2017-04-21 |
| Esterase | JCH | Class 1 | Hematology | No | 2016-01-21 |
| Stains, Dye Solution | LEE | Class 1 | Hematology | No | 2016-01-21 |
| Hematoxylin, Iron, Weigert'S | IAE | Class 1 | Hematology | No | 2016-01-21 |
| System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection | SBB | Class 3 | Unknown | No | 2025-02-07 |
| Test, Leukocyte Peroxidase | GIA | Class 1 | Hematology | No | 2016-01-21 |
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