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labcon.com4QUALITYOUR TESTING & PROTOCOLSEvery Labcon product lot is produced in a tightly controlled environment and subjected to rigorous physical and biological testing procedures to ensure optimal performance. Our products consistently meet all stated standards for precision, clarity, warp, centrifugation, and freedom from contamination. We stand behind these products, and will replace any that fail to meet our published standards. Biological Testing%uf0fc Endotoxin (Pyrogen)%uf0fc Bioburden%uf0fc Nuclease-RNase/DNase%uf0fc Human DNA %uf0fc Adenosine Triphosphate (ATP)%uf0fc Sperm Motility Assay (Non-Cytotoxicity)%uf0fc Mouse Embryo Assay (Non-Cytotoxicity)%uf0fc ProteaseMaterial and Substance Testing%uf0fc Low Trace Metals (USP) (1ppm)%uf0fc Ultra Low Trace Metal (1ppb)%uf0fc PFAS (free of 62 distinct compounds)Performance and Physical Testing %uf0fc Autoclavability%uf0fcDimensional and Functional Testing%uf0fc U.S. DOT and IATA%uf0fc CO2 Dry Ice Shipment%uf0fc UV Blocking (UVA, UVB, UVC)Conformity & RegulationsRegularly audited to conform with external assessment from regulatory agencies including FDA, CE, and ISO per ISO 9001:2015 to meet requirements of U.S. 21 CFR and US FDA GMP.Labcon%u2019s products are made of high-quality, 100% virgin polypropylene (PP), high-density polyethylene (HDPE), or polystyrene resin and are certified free of Bisphenol A (BPA), phthalates, and cytotoxic effects. Bovine Spongiform Encephalopathy/ Transmissible Spongiform Encephalopathy (BSE/TSE) compliant. Resins are USP Class-VI certified, RoHS, FDA regulation CFR 21, and are free of Substances of Very High Concern (SVHC), REACH compliant, and are FDA approved for food contact. Our resins are pre-tested for clarifying agents or molding additives that could affect experiments, such as oleamide and DiHEMDA. No Latex was used in the manufacturing of the product. This also includes all the packaging and shipping materials used in the production of all items. The only time the product or packaging may come in contact with Latex would be from the Latex gloves that production employees are required to wear for the purpose of clean handling and to avoid biological contamination of the products.Electron Beam Sterilization & Dose ValidationLabcon sterile products are irradiated within a dose range (15.2-35 kGy) necessary for the stated Sterility Assurance Level (SAL) of 10-6. Our sterilization process is continuously audited through quarterly bioburden perform as required according to the ANSI/AAMI/ISO 11137, which legally allows these sterile products to be used in clinical, diagnostic, and research settings. Expiration date is shown on the label.California Safe Drinking Water and Toxics Enforcement Act (Prop 65)Labcon products are certified to be free of the listed chemicals as referenced in the California Safe Drinking Water and Toxic Enforcement Act of 1986, (Prop 65) revised May 25, 2018.RoHSAll our products are compliant with European Directive 2002/95/EC/-2011/65-2015/863 and does not contain any of the listed substances.REACH & SVHCOur products are free of Substances of Very High Concern (SVHC) and all our products are European REACH Regulation (EC) No 1907/2006 compliant.Oleamide & DiHemdaDisposables are made from 100% virgin polypropylene, polyethylene or polystyrene and are free of Oleamide and DiHEMDA.Bisphenol A (BPA) & PhthalatesAll Labcon disposables are made from 100% virgin polypropylene, polyethylene or polystyrene and are free of Bisphenol A and Phthalates.Bovine Spongiform Encephalopathy-Transmissible Spongiform Encephalopathy (BSE/TSE) Our products contain resins that are either manufactured without the use of bovine constituents or are processed to eliminate them during distillation. These conditions exceed the European Union standard as listed in the 22nd Commission Directive EC 98/16/EC of March 5th, 1998 as annexed to council Directive EC 76/768/EEC and further Amendment 419 Annex II of 12 June 2001, and as agreed to by the Scientific Committee on Cosmetics Recommendations concerning Tallow derivatives for processing conditions of 200%u00baC and 40 bars for 20 minutes. The manufacturer does not store any products of animal origin, including animal proteins, in any manufacturing areas of their facility or warehouses.Per- and Polyfluoroalkyl Substances (PFAS)Labcon's PFAS-free products were thoroughly tested to ensure the products manufactured are free of PFAS compounds. Testing methods followed the guidance of: EPA Method 537 for specific PFAS compounds and EPA Method 300.0 for inorganic ions. Tests were performed via Liquid ChromatographyMass Spectrometry (LC-MS), Isotope Dilution Analyte (IDA), and Combustion Ion Chromatography (CIC).DOWNLOAD ONLINE CERTIFICATES:Labcon's compliance certifications: labcon.com/certificationsBiological testing certifications: labcon.com/testingProduct-specific certifications: labcon.com/certificatesOverviewRefer to the icons that appear on each product page or the product certificates to determine which biological, performance, and material tests apply to specific products.