- Physicians Office Resource

Geenius SW V2.0 & APF V2.0 Installation Kit
Geenius - 12012851

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using a chemiluminescent immunoassay method.

Environmental Conditions

No Data Available

Device Sizes

1 Each

1 Each

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QHM

Device Name: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

Device Class: U

Physical State: May include reagents, buffers, tubes, plates and other components necessary to run the assay

Definition: For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens

Submission Type ID: 3

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enzyme-linked immunosorbant assay, chemiluminescence, other antibody-antigen interaction and detection

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: Human specimens including blood, serum, plasma, urine, other samples

Regulation Number: 610.40

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 03610522168064

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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