Search Results
Found 1 results
510(k) Data Aggregation
K Number
K013819Device Name
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
Manufacturer
SIERRA DIAGNOSTIC, L.L.C.
Date Cleared
2002-02-28
(104 days)
Product Code
JTW
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
SIERRA DIAGNOSTIC, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is intended for use in the collection, preservation, and transportation of urine specimens at temperatures not exceeding 60°C for testing with the Abbott LCx® Neisseria qonorrhoeae and Chlamydia trachomatis assays.
Device Description
The device is comprised of a urine collection cup containing of a nucleic acid chemical preservative. The device allows urine specimens for LCx® gonococcal or chlamydial testing to be preserved for up to 6 days at temperatures not to exceed 60°C. Inert indicator beads are included in the urine cup as an indicator that a preservative is present in the sample.
Ask a Question
Page 1 of 1