- Physicians Office Resource

OSOM iFOB Control Kit
OSOM iFOB Control Kit - 1000

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin).

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: OSL

Device Name: Control, Fecal Occult Blood

Device Class: 2

Physical State: The control solutions are in the aqueous form.

Definition: Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.

Submission Type ID: 4

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The test is based on the detection of human hemoglobin. The negative control solution contains only buffer. The positive control solution contains human hemoglobin at a specified concentration. The control solution is placed in the test device according to the manufacturer's instructions. The negative control produces one distinct color band in the control area and the positive control produces two color bands in the control and the test area of the lateral flow strips of the test device.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Occult blood in human stool.

Regulation Number: 864.6550

Third Party Flag: N

Medical Specialty: HE

Device Identifiers

Device Id: 00742860100185

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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