Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1938173

FEI Number

1938173

Entity Name

SIGMA-ALDRICH MANUFACTURING, LLC

City/State/Country

ST. LOUIS, MO, US

Establishment Address

545 SOUTH EWING AVE., ST. LOUIS, MO 63103, US

Establishment Type(s)

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

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

K040898

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Unknown	Class 3	N/A	2024-11-19
JCI	Acid Phosphatase, Cytochemical	Hematology	Class 1	864.1850	2016-01-21
KKS	Acid, Periodic	Hematology	Class 1	864.1850	2016-01-21
ICH	Congo Red	Hematology	Class 1	864.1850	2012-06-29
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Unknown	Class 3	N/A	2018-07-06
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2012-06-28
JCC	Ph Buffer	Pathology	Class 1	864.4010	2012-06-29
JCJ	Alkaline Phosphatase	Hematology	Class 1	864.7660	2016-01-21
GHQ	Stain, Fetal Hemoglobin	Hematology	Class 2	864.7455	2016-01-28
NQI	System, Immunomagnetic, Circulating Cancer Cell, Enumeration	Immunology	Class 2	866.6020	2016-01-28
GGH	Iron Stains	Hematology	Class 1	864.1850	2016-01-21
NRS	Control Material, Blood Circulating Epithelial Cancer Cell	Hematology	Class 2	864.8625	2016-01-28

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1938173. Last updated year: 2026. Please use registration number 1938173 when referencing this establishment in official correspondence.