List of Contributions

I think this can either be considered "Procedure Pack" or enjoys an exemption similar to custom or singular devices. This could also be simply a distributor if the goods were already in inventory as part of the business. ------------------------------ David Manalan Principal, INQC Consulting INQC ...

Talk to the notified body that issued the CE mark. David A. Manalan978-266-1220 dmanalan@alum.MIT.edulinkedin.com/in/davidmanalan

It sounds like a medical device- according to your company. Proprietary Name: Lumin; Lumin Bullet Classification Name: DISINFECTANT, MEDICAL DEVICES Product Code: LRJ Device Class: 1 Regulation Number: 880.6890 Medical Specialty: General Hospital Registered ...

Sounds like it's a medical device, so it is exempt from FIFRA (EPA). 3B has it listed as such.Proprietary Name:Lumin; Lumin BulletClassification Name:DISINFECTANT, MEDICAL DEVICESProduct Code:LRJDevice Class:1Regulation Number:880.6890Medical Specialty:General HospitalRegistered Establishment Name:3B ...

Just posted by FDA http://s2027422842.t.en25.com/e/er?utm_campaign=2020-03-17%20Mar%2017%20Update%3A%20New%20Information%20on%20Diagnostic%20Testing%20for%20SARS-CoV-2&utm_medium=email&utm_source=Eloqua&s=2027422842&lid=12090&elqTrackId=59B1C67438E203834144B4C9652022F4&elq=5690af89708b4ebf97184346b ...