DELTALAB 2020 catalogue by chapters
318Pages

Dear customers, distributors, suppliers and friends, It is again a pleasure to be able to adress all of you through this new edition of DELTALAB’s Catalogue. A Catalogue that highlights the work done by our company in these more than 40 years, and that wants to respond to the needs of our customers. Our well known company phylosophy: innovation, quality, service and efficiency, has been and will be always linked to our daily work, with a clear final objective: our customers’ satisfaction. At the doors of the beginning of a new decade our market continues to show solidity, being naturally an evolving market. The increasing automation of processes and the search for higher speed and reliability in diagnosis are clearly influencing the demand for new solutions. Finding the right scale to grow in this new competitive environment, increasing investment in R&D, developing our production and operational processes in search of higher productivity, adapting the forthcoming regulatory changes are some of the challenges that as of today, we are facing them and will be decisive to continue competing for the future of our market. From Deltalab, we take these new challenges with the same enthusiasm that we have put through all these years, and we will redouble our efforts to continue having the best solutions for our clients. For this, we want to count, as always, with your invaluable collaboration. Your success will be ours too. We hope that this new edition of our Catalogue will help us to meet our common objectives and be the tool that gives us the key to this near future succes. José Sáez Mateos CEO

CERTIFICATIONS OF THE INTEGRATED MANAGEMENT SYSTEM (quality and environment) ISO 9001: 2015 Quality management systems. ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes. ISO 14001: 2015 Environmental management systems 2

DELTALAB ISO CERTIFICATIONS Deltalab’s Quality Management System is certified as per ISO 9001:2015 and ISO 13485:2016 standards. Since August 2019, Deltalab has been granted the ISO 14001:2015 Certification. This standard ensures that our companies have an Environmental Management System, which allows us to control the environmental impact of our products and activities. Deltalab, being a company committed with the environment protection, has decided to implement the mentioned Environmental Management System to reduce as much as possible the environmental impact. The plastic materials of...

1. MEDICAL DEVICES (MD) According to Regulation UE Nº 2017/745 on Medical Devices (that will replace Directive 93/42/CEE) a Medical Device is anyinstrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: · Diagnosis, prevention, monitoring, prediction, prognosis, treatment or allevation of disease, · Diagnosis, monitoring, treatment, alleviationof,or compensation for, an injury or disability, · Investigation, replacement...

LEGISLATION OF MEDICAL DEVICES AND PPE 2. MEDICAL DEVICES FOR IN VITRO DIAGNOSTIC (IVD) According to Regulation EU Nº 2017/746 on medical devices for in vitro diagnosis (that will replace Directive 98/79/EC), an in vitro medical device is “any medical devicewhich is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone, solely or principally for the purpose of providing information on one or more of the following: · concerning a physiological or pathological process or state; · concerning congenital...

USEFUL INFORMATION PRODUCT PACKAGING SYMBOLS USED IN LABELING AND INFORMATION ON MEDICAL DEVICES (in accordance with UNE-EN ISO 15223-1: 2016) Use-by date Temperature limit Catalogue number STERILE A Sterilized using aseptic processing techniques In vitro diagnostic medical device Sterilized using irradiation TRANSPORT CONTAINERS: CAPACITY: • 20 feet: 28 m3 maximum • 40 feet: 58 m3 maximum • 40 HC feet: 68 m3 maximum PALLETS: • maximum height land transport: 2.40 m • maximum height sea transport: 2.10 m • width x depth european pallet: 80 x 120 cm • width x depth american pallet: 100 x 120 cm

SALES CONDITIONS SALES CONDITIONS · Goods are shipped at the purchaser’s risk and on the purchaser’s account. · Goods are considered delivered, and at the responsibility of the purchaser, from their shipment from our warehouses. Any problem of transport or other is therefore the entire responsibility of the purchaser from that moment. · Goods delivered are the property of DELTALAB S.L. until paid in full. In case of discrepancy, we will be governed by the courts of Barcelona. · MINIMUM ORDERING QUANTITY (per total order): According to our price list. · MINIMUM ORDER QUANTITY (per product):...

Alphanumerical Identification DNAse and RNAse free Autoclavable (see more information about autoclaving in page 298) Suitable for PCR Suitable for QPCR (Real Time PCR) High resistance tube Product suitable for food use New Directive 98/79/EC or Regulation 2017/746 (in Vitro Diagnostic medical device) Directive 93/42/EEC or Regulation 2017/745 (low risk medical device) Directive 93/42/EEC or Regulation 2017/745 (Moderate risk, sterile medical device) Directive 89/686/EEC (Personal protective equipment) The technical data (dimensions, capacities and resistances) specified in this catalogue...

50 Cell culture. Molecular biology 72 Haematology. Biochemistry 90 Histology. Microscopy and staining 114 Containers. Sampling 140 Tubes, microtubes and cryovials 162 Cold storage 176 Liquid handling 208 Sample storage 240 Hygiene, safety and general labware 274 Laboratory and industrial packaging 294 Technical information 302 Index

SWABS FOR MICROBIOLOGICAL SAMPLING - Swabs are used for biological sampling. - Specially used for processing samples which, after being coloured, will be analysed by microscopy. - Also suitable for isolations in culture medium. - Another important use is its capacity to spread dishes by dissemination techniques (for example for susceptibility testing by Kirby-Bauer or by E-test). SWABS The swabs intended for the collection and transport of microbiological samples are considered invasive medical devices for temporary use. As such, they comply with the safety and performance requirements...