← FDA Medical Device Classifications

Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

GQS · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3400

Classification

FDA Product Code
GQS
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 866.3400
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
11
Registered establishments
5

Source

Authoritative
FDA Device Classification database
Machine
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