Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
Publicado el 24 de julio de 2013 · Inicio del retiro: 12 de abril de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of Un
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Paa Laboratories Inc
- Distribuidor
- Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
- Lote
- 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Canada
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