Sigma-Aldrich Manufacturing, LLC
St. Louis, MO, US
SIGMA-ALDRICH MANUFACTURING, LLC appears in FDA device records in St. Louis, MO. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Sigma-Aldrich Manufacturing, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Sigma-Aldrich Mfg LLCrecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1938173 | 1938173 | SIGMA-ALDRICH MANUFACTURING, LLC | 545 SOUTH EWING AVE., ST. LOUIS, MO 63103 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JCIAcid Phosphatase, Cytochemical
- KKSAcid, Periodic
- JCJAlkaline Phosphatase
- ICHCongo Red
- NRSControl Material, Blood Circulating Epithelial Cancer Cell
- JCHEsterase
- PPMGeneral Purpose Reagent
- IAEHematoxylin, Iron, Weigert'S
- GGHIron Stains
- HYZMethenamine Silver
- JCCPh Buffer
- HYESolution, Fontanna Silver
- GHQStain, Fetal Hemoglobin
- LEEStains, Dye Solution
- PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- SBBSystem, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
- NQISystem, Immunomagnetic, Circulating Cancer Cell, Enumeration
- GIATest, Leukocyte Peroxidase
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0977-2010 | Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077. | Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances. | Terminated | ||
| Z-0976-2010 | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a 6x100-ml. bottle package. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null lymphocytes. | Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances. | Terminated | ||
| Z-0974-2010 | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes. | Some of the product was contaminated with Pseudomonas mendocina | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain