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510(k) Data Aggregation
K Number
K121039Device Name
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
Manufacturer
COPAN FLOCK TECHNOLOGIES
Date Cleared
2012-05-25
(50 days)
Product Code
JTW
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
COPAN FLOCK TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture.
Device Description
Copan MSwab Collection, Transport and Preservation System is supplied in two different formats: a collection kit format and a tube only format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium and a small sterile peel pouch containing one specimen collection swab that has a tip flocked with soft nylon fiber. The tube only format consists of a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium. The MSwab is intended for single use. MSwab transport and preservation medium is a maintenance medium comprising TRIS HCl. EDTA. TRIS Base, Dimethyl Sulfoxide (DMSO) and Bovine Serum Albumin. The medium is designed to maintain the viability of Gram positive aerobic and facultative anaerobic bacteria. HSV 1 and HSV 2 during transit to the testing laboratory. The nylon flocked specimen collection swab provided in each collection kit of the Copan MSwab Collection. Transport and Preservation System has a solid plastic shaft with a molded breakpoint site.
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