← FDA Medical Device Classifications

Epstein-Barr Virus, Other

LSE · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3235

Classification

FDA Product Code

LSE

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 866.3235

Review panel

MI

Medical specialty

Microbiology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

56

Registered establishments

15

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown