Hi all,
Which directive is relevant for registering Analyte Specific Reagents (ASR) and General Purpose Reagents (GPRs) in EU?
For RUO instruments,we follow LVD and EMC Directives and place CE Marking.
But for ASR and GPR (antibodies, cell culture medium, etc..) which regulations in EU apply so that we can put CE Marking?
Thanks,
Sreenu
Which directive is relevant for registering Analyte Specific Reagents (ASR) and General Purpose Reagents (GPRs) in EU?
For RUO instruments,we follow LVD and EMC Directives and place CE Marking.
But for ASR and GPR (antibodies, cell culture medium, etc..) which regulations in EU apply so that we can put CE Marking?
Thanks,
Sreenu