Registrations

U.S. FDA Registered

Labcon operates from a registered medical device manufacturing facility.

ISO 9001 Registered

Labcon maintains a registered ISO 9001:2015 quality system.

Directive 98/79/EC

Labcon is registered to the European IVD Directive.

Registrations & Certifications

The registrations for our systems and processes and certifications to specific standards. This documentation is included on the applicable compliance certificates.

Regulatory Registrations

FDA

The Labcon manufacturing facility has been registered to U.S. FDA standards as a medical device manufacturing facility since 1965. We manufacture listed medical devices. Our facility registration number is 2916657.

CE

Labcon products in grouped classes are registered to the European IVDD 98/79/EC. Registered classes are EDMA Class 24 09 Micro Biology Disposables and EDMA Class 21 01 1001 CH Hardware and Assessories. Our registrar is MDI EUROPA and our registration number is DE/CA09/0760/IVD/158.

Quality System Registration

ISO 9001

Labcon has maintained a registered ISO 9001 quality system since 1997. Our registrar is DQS and our registration number is 10001183.

Environmental Product Registration

ACT

These products have been independently audited for the Accountability, Consistency, and Transparency (ACT) Environmental Impact Factor label for laboratory products. A published score for these products is shown at act.mygreenlab.org.

Certifications

Prop 65

Labcon products are certified to be free of any of the “listed chemicals” as referenced in the California Safe Drinking Water and Toxic Enforcement Act of 1986, (Prop 65) as revised May 25, 2018.

RoHs

All our products are compliant with European Directive 2002/95/EC/-2011/65-2015/863 and contain none of the listed substances.

SVHC

Our products are free of Substances of Very High Concern (SVHC) and all our products are European REACH Regulation (EC) No 1907/2006 compliant.

BSE

Our products contain resins that are either manufactured without the use 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 200ºC 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.

Additives

Disposables are made from 100% virgin polypropylene, polyethylene or polystyrene and are free of Oleamide and DiHEMDA processing agents.

Phthalates

All Labcon disposables are made from 100% virgin polypropylene, polyethylene or polystyrene and are free of Bisphenol A and Phthalates plastic processing agents.

Testing Procedures & Protocols

Our biological and physical testing protocols and procedures can be accessed at the link to the right.