← FDA Medical Device Classifications

Reagents, Clostridium Difficile Toxin

LLH · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2660

Classification

FDA Product Code

LLH

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 866.2660

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

42

Registered establishments

24

Source

Authoritative

FDA Device Classification database

Machine

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