Personal Use Kit OC-Auto, for Houston, TX

Personal Use Kit OC
OC-Auto - OCPU-VA1 213261

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OOX

Device Name: Automated Occult Blood Analyzer

Device Class: 2

Physical State: The system consists of an analyzer, test reagents (antibody, calibrators and controls) and collection devices containing buffer.

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.

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The test reagent contains an immunoassay utilizing monoclonal and polyclonal antibodies for human hemoglobin. A light beam measures the antibody reaction, i.e. the absorbance fo the reaction mixture measures the concentration of hemoglobin in the specimen.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: fecal samples

Regulation Number: 864.6550

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00816917021676

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A