Personal Use Kit OC
OC-Auto - OCPU-LAWV
Device Description
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).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00816917023670
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
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