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510(k) Data Aggregation
K Number
K103805Device Name
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
Manufacturer
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
Date Cleared
2011-01-25
(28 days)
Product Code
LIO
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
**MEDICAL WIRE **& EQUIPMENT COMPANY (BATH) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medical Wire & Equipment Σ-Transwab (Sigma-Transwab ) Specimen Collection and Transport System is intended to preserve the viability and infectivity of microbiological specimens after their collection and during transport from the collection site to the testing laboratory. Σ-Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.
Device Description
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K Number
K082472Device Name
VIROCULT, MODEL MW950
Manufacturer
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
Date Cleared
2008-12-30
(124 days)
Product Code
LIO
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
**MEDICAL WIRE **& EQUIPMENT COMPANY (BATH) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.
Device Description
Each Virocult® device comprises a sterile peel pouch containing a rayon- tipped swab used to collect the sample and a tube containing an open cell polyurethane pad soaked with Virocult® virus transport medium. After sampling, the swab applicator is placed inside the tube, where the bud is bathed with the liquid from the foam pad.
Virocult® medium consists of a phosphate-buffered balanced salt solution, glucose, lactalbumin hydrolysate to stabilise the virus particles, and antibiotics to inhibit the growth of other microorganisms that may be present in the clinical specimen.
The rayon- tipped swab will suit most general applications such as mouth, nose, throat and skin.
To use Virocult®, the sterile peel pouch is opened, and the cap removed from the transport tube. The applicator swab is removed from the pouch and used to collect the clinical specimen. During specimen collection, the applicator should only fouch the area where the infection is suspected.
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