Product code OOX

Device name

Automated Occult Blood Analyzer

Medical specialty

Hematology

Device class

2

Regulation number

864.6550

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

Source

FDA openFDA device classification dataset