← FDA Medical Device Classifications

Kit, Test (Donors), For Bloodborne Pathogen

MYZ · Class II — Moderate Risk (510(k) clearance required) · Unknown

Classification

FDA Product Code

MYZ

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

—

Review panel

IM

Medical specialty

Unknown

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

4

Source

Authoritative

FDA Device Classification database

Machine

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