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510(k) Data Aggregation
K Number
K061301Device Name
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
Manufacturer
COPAN DIAGNOSTICS, INC.
Date Cleared
2006-06-23
(44 days)
Product Code
JTW
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
COPAN DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.
Device Description
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is supplied in a collection kit format. Each collection kit consists of a sterile package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml of Liquid Amies transport medium and a small sterile peel pouch containing one of two sizes of a specimen collection swab that has a tip flocked with soft nylon fiber.
The Liquid Amies transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium and magnesium salts and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability of aerobic bacteria, anaerobic bacteria and fastidious bacteria such as Neisseria gonorrhoeae during transit to the testing laboratory.
The nylon flocked specimen collection swabs provided with the Copan ESwab Collection and Transport System have a solid plastic shaft with a molded breakpoint site. Copan ESwab Collection and Transport System kits are available with two different size nylon flocked swab options to facilitate the collection of specimens from various sites on a patient.
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K Number
K042970Device Name
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
Manufacturer
COPAN DIAGNOSTICS, INC.
Date Cleared
2004-12-07
(40 days)
Product Code
JSM
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
COPAN DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.
Device Description
The Copan UTM-RT System includes a universal transport medium that is room temperature stable and that can sustain viability (and infectivity) of a plurality of organisms that include clinically important viruses, chlamydiae, mycoplasma and ureaplasma during transit to the testing laboratory. The formulation of UTM-RT medium includes protein for stabilization, antibiotics to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.
Copan UTM-RT System medium is provided in screw-cap tubes designed for transport of the clinical sample. Copan UTM-RT System is also supplied as a sample collection kit that comprises a package which contains one screw-cap tube of UTM-RT medium and a peel pouch incorporating one or two sterile specimen collection swabs. A range of UTM-RT sample collection kits are available which incorporate different types of shaft swabs which facilitate the collection of specimens from different sites of the patient.
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K Number
K001780Device Name
COPAN VIRAL TRANSYSTEM
Manufacturer
COPAN DIAGNOSTICS, INC.
Date Cleared
2001-07-31
(413 days)
Product Code
JSM
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
COPAN DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993161Device Name
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
Manufacturer
COPAN DIAGNOSTICS, INC.
Date Cleared
1999-11-09
(48 days)
Product Code
JTW, JTY
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
COPAN DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Copan Easy-Swab Collection and Transport System products are sterile, single-use specimen collection chambers intended to preserve the viability of aerobic microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic bacteria.
Device Description
The Copan Easy-Swab is offered in two configurations. The Copan Easy-Swab I is offered with a single swab applicator and the Copan Easy-Swab II is offered with two swab applicators. The Copan Easy-Swab is composed of a sterile peel pouch containing one or two swab applicators inside the transport tube. The swab applicator incorporates a polyurethane foam tip on a plastic shaft secured to a cap. The tube is manufactured from polypropylene.
To use the Copan Easy-Swab Collection and Transport System, the sterile peel pouch is opened and discarded. The applicator swab is removed from the tube and used to collect the clinical specimen. During specimen collection, the applicator tip should only touch the area where the infection is suspected. The applicator swab is returned to the transport tube, the cap firmly closed, and the specimen sent to the laboratory for analysis. After use, the tubes and swabs must be disposed of according to hospital or laboratory procedures for infectious waste.
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