← FDA Medical Device Classifications

Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

DBE · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5120

Classification

FDA Product Code

DBE

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 866.5120

Review panel

IM

Medical specialty

Immunology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

6

Registered establishments

3

Source

Authoritative

FDA Device Classification database

Machine

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