50 years of service to science & industry
The Bacterial Endotoxins Test (BET)
also known as the Limulus Amoebocyte Lysate test (LAL)
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If your products (e.g. medical devices, pharmaceuticals, vaccines, infusion fluids, etc.) MUST have a bacterial endotoxin ("pyrogen") content below a certain level, as demanded by the global authorities?
If you need the official certificate of analysis e-mailed to you within 24 hours of receipt of your samples?
if you demand state-of-the-art technology?
If you require monitoring of bacterial activity in e.g. dialysis fluids, water supplies, aircondition systems, dairy products, food processing lines, etc.?
If you demand 100% discretion and competitive prices?
You are cordially invited to call us or send us an e-mail right away!
Our analyses are performed in strict accordance with the US FDA, the USP, the EP, the JP, WHO INT. PHARMACOPOEIA, the Australian therapeutic goods order and all other international standards, including the DS/EN 14031:2003 concerning airborne endotoxin.
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Recently, we have added recombinant LAL reagents that are not based on raw material from animals: Recombinant Factor C (rFC) and the most recent development PyroSmart NextGen Recombinant LAL, a full recombinant cascade reagent, manufactured and marketed by Associate of Cape Cod, Inc.
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All procedures, materials, and methods are described in detail on each and every Certificate of Analysis.
Audited & accredited by:
About
Scan Dia Labs
HISTORY
Established in Denmark on June 5th 1975 by Tom Mikkelsen, LAL Test pioneer and Founder,
Scan Dia Labs is the oldest and most experienced Endotoxins Testing House in the world.
We master all LAL assays recommended by the pharmacopoeias, but are specialized in the ultra-sensitive, quantitative kinetic-turbidimetric assay.
We are authorized by the Danish Health and Medicines Authority and audited regularly by major international clients in accordance with the June 2012 Compliance Protocol ("Guidance for Industry: Pyrogen and Endotoxins testing") issued jointly by the U.S. Department of Health and Human services, the U.S. FDA, CDER, CBER, CVM, CDRH and ORA.
The blue blood of the horseshoe crab is the only source of the Limulus (Tachypleus) Amoebocyte Lysate used in the LAL assay to detect Gram-negative bacterial endotoxins in sub-picogram concentrations.
During 29 underwater expeditions around the world, we have documented and filmed the four existent species of horseshoe crabs, in order to help protect and preserve their natural habitats.
We have also participated in a significant number of expeditions to help chart the global fossil record of this unique marine invertebrate, which has an unbroken evolutionary history spanning 500 million years.
SCAN DIA LABS
Tom Mikkelsen, Founder and CEO