FDA-Device2017-09-20Class II
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
bioMerieux, Inc.
Hazard
Some anomalies have been identified during manufacturing controls.
Sold states
Worldwide Distribution: US (nationwide) to states of: GA, IL, IN, MA, NC & TX and to countries of: Austria, France, Germany, Hong Kong, Italy, Netherlands, Spain, Sweden, Switzerland, Thailand and United Kingdom.
Affected count
15 US
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3119-2017Don't want to check this manually?
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