← FDA Medical Device Classifications

Whole Blood Plasma, Antigen, Antiserum, Control

DGQ · Class I — Low Risk (general controls) · Immunology · 21 CFR 866.5700

Classification

FDA Product Code
DGQ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 866.5700
Review panel
HE
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
5

Source

Authoritative
FDA Device Classification database
Machine
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