- Physicians Office Resource

Customized Personal Use Kit OC
OC-Auto - OCPU-ASP-FP

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

Handling Environment Temperature - Degrees Celsius

30.00
2.00

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 Identifiers

Device Id: 00816917023892

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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Customized Personal Use Kit OC-Auto