← FDA Medical Device Classifications

Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control

DEF · Class I — Low Risk (general controls) · Immunology · 21 CFR 866.5425

Classification

FDA Product Code

DEF

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 866.5425

Review panel

IM

Medical specialty

Immunology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

1

Source

Authoritative

FDA Device Classification database

Machine

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