Swab for sampling: MDD 93 / 42 / CEE. CE 0318, Class IIa Medical Device. Tube with transport media: IVD 98 / 79 / CE In Vitro Diagnostic Medical Device.
USE Medium specifically formulated for the transport of viruses and their conservation during transport from the consultation to the laboratory.
The set is composed by:
• A 13 x 165 mm sterile round bottom tube with cap, made of non-distorting polypropylene, and a polyethylene blue cap that perfectly seals the tube containing the transport media without sponge.
• A swab consisting of polystyrene slightly flexible with a viscose head. Under pressure, can be cut with scissors.
• A label that seals the cap to the tube. The label provides space for patient’s name, sample collection date and hour, number, doctor, specimen nature and hospital name. Also indicated are the expiry date, batch number, product description and brand, and instructions for use.
• Batch number, expiry date, product code, brand and description are printed on the peelpack.
Swabs are manufactured in a Clean Room. The CE Mark Class IIa allows their use in surgery as invasive products. Expiry date: 18 months from sterilisation date.
The swabs are made for taking microbiological samples in contact with the patient’s skin or open wounds are manufactured according to ISO 9001 and ISO 13485 standards; They also hold the CE Marking, which certifies them as suitable for free sale in all countries of the European Union. A copy of the three certificates can be supplied upon request.
THE TRANSPORT MEDIUM FOR VIRUS This medium, useful for transporting nasal, nasopharyngeal, and samples from ocular, dermal, or mucosal lesions, keeps many types of viruses viable for more than 72 hours.
Suitable, among many others, for:
• Papilloma • Pseudo-rabies (suis herpesvirus)
• Avian influenza (H7N1)
• Influenza A (H1N1) or pandemic H1N1 / 09
It is a complex medium of protein base (bovine albumin) in buffered saline. It also includes antibiotics that inhibit Gram positive, Gram negative bacteria and fungi. It is manufactured in liquid phase to facilitate both the cultivation in cell lines and the adaptation to immunological techniques of ELISA and PCR.
STANDARDS Directive 98/79/EC. “In vitro” diagnostic medical devices Directive 93/42/EEC. Medical Devices.
Standards related to the Quality System and / or the product:
• UNE EN ISO 9001 of Quality Management Systems.
• UNE EN ISO 13485 of Health Products - Quality Management Systems.
• UNE EN ISO 14971 Health Products Risk Management.
• UNE EN ISO 15223-1 Medical devices. Symbols to be used on labels, labeling and information to be supplied. Part 1: general requirements.
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