← FDA Medical Device Classifications

System, Blood Culturing

MDB · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2560

Classification

FDA Product Code

MDB

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 866.2560

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

67

Registered establishments

19

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown