EBF has been manufacturing newborn screening devices for more than 40 years. EBF is the exclusive provider of 903 filter paper worldwide for diagnostic use and has extensive experience in the design and manufacture of 903 diagnostic devices and procedure packs. EBF has been the exclusive manufacturer of dried blood spot collection devices for Schleicher & Shuell, Whatman, and GE Healthcare.
Our goal is to exceed customer requirements by leveraging our extensive manufacturing experience and providing superior customer service. We provide a high level of product customization and will work with you to provide a high quality product with the lowest possible lead time to meet your needs.
EBF’s corporate office and manufacturing facility are located in Greenville, SC, United States.
903 Sample Collection Device
In 1962, Dr. Robert Guthrie first published procedures for screening newborns for Phenylketonuria (PKU). The 903 Sample Collection Device has played an important role in this screening, assisting in the widespread testing of PKU. This has resulted in early detection and intervention for tens of thousand babies in the US. Today, neonatal screening for anywhere between three to twenty or more analytes, including congenital hypothyroidism, galactosaemia, branched-chain ketonuria, maple sugar urine disorder, and sickle-cell anaemia is possible with our 903 sample collection paper. More recently, with the advent of tandem mass spectrometry technology, many programs are adding less frequently occurring disorders to their panel of analytes, including MCAD, cystic fibrosis, and a range of amino acid disorders. In 1998, the 903 sample collection paper became the international standard for body fluid sample collection, transport, analysis, and archiving.
Purity, consistency, and excellent absorption are important characteristics for neonatal blood collection papers. The paper must be free from impurities that may interfere with the quality or composition of the sample. It must also be validated in compliance with the requirements of the CLSI LA4-A5 consensus standard. 903 Sample Collection Devices meet these specifications and they are listed as an FDA Class II Medical Device. In Europe, they are sold as a “CE” -marked “in vitro diagnostic” in compliance with 98/79/EC.