← FDA Medical Device Classifications

Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

GNM · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3145

Classification

FDA Product Code

GNM

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 866.3145

Review panel

MI

Medical specialty

Microbiology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

9

Registered establishments

4

Source

Authoritative

FDA Device Classification database

Machine

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