← FDA Medical Device Classifications

Gonococcal Antibody Tests

LGB · Class III — High Risk (PMA approval required, life-sustaining) · Microbiology · 21 CFR 866.3290

Classification

FDA Product Code

LGB

Device class

Class III — High Risk (PMA approval required, life-sustaining)

Regulation

21 CFR 866.3290

Review panel

MI

Medical specialty

Microbiology

Submission type

2

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

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