Data / Medical devices / United States / Sigma-Aldrich Manufacturing, LLC
Sigma-Aldrich Manufacturing, LLC: FDA-registered device maker in St. Louis, MO, United States, 2 510(k) clearances
Sigma-Aldrich Manufacturing, LLC is registered with the FDA (registration 1938173) in St. Louis, MO, United States. It lists 19 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 21, 2010. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1938173
- Address
- 545 South Ewing Ave., St. Louis, MO, United States, 63103
- Owner or operator
- MilliporeSigma (1216103)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 2, 2002
- Registered through
- 2026
- Brand names listed
- -NAPHTHYL ACETATE, -NAPHTHYL BUTYRATE ESTERASE, KIT. PART 1, -NAPHTHYL BUTYRATE SOLUTION, 20X PBS IHC Wash Buffer + Tween 20, 20X TBS IHC Wash Buffer + Tween20, A-NAPHTHYL ACETATE SOLUTION, ACETATE SOLUTION, ACID PHOSPHATASE KIT, PART 1 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2010 | K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | NQI | Substantially Equivalent | Veridex, LLC | accessdata.fda.gov |
| June 28, 2004 | K040898 | CELLSEARCH EPITHELIAL CELL CONTROL KIT | NRS | Substantially Equivalent | Veridex, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 8, 2009 | 53956 | Not yet classified | Terminated | 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 vi | Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances. | accessdata.fda.gov |
| September 4, 2009 | 53560 | Not yet classified | Terminated | 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 | Some of the product was contaminated with Pseudomonas mendocina | accessdata.fda.gov |
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Updated December 21, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.