Sekisui Diagnostics, LLC

Entity profile compiled from public source records

Public Record Profile Registrations: 3 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 1000520007, 3002806809, 3017772438
Owner Operator Numbers 10035388
Locations Covered CHARLOTTETOWN Prince Edward Island, CA; SAN DIEGO, CA, US; San Diego, CA, US

Registered Establishments (3)

Registration # Establishment Name Location Establishment Type(s) Action
2030538 Sekisui Diagnostics, LLC SAN DIEGO, CA, US Manufacture Medical Device View Details
3017772438 Sekisui Diagnostics, LLC San Diego, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
8020316 Sekisui Diagnostics P.E.I. Inc. CHARLOTTETOWN Prince Edward Island, CA Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0015-2014 Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD. Reason: Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results. 2013-09-16 Terminated View Details

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