← FDA Medical Device Classifications

Reagent, Leishmanii Serological

LOO · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3870

Classification

FDA Product Code

LOO

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 866.3870

Review panel

MI

Medical specialty

Microbiology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

2

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

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