← FDA Medical Device Classifications

Reagent, Russel Viper Venom

GIR · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.8950

Classification

FDA Product Code

GIR

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.8950

Review panel

HE

Medical specialty

Hematology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

16

Registered establishments

12

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown