MULTISPOT HIV
Bio-Rad - 25228
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 within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses and may be available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- 50 Tests
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MZF
Device Name: Test, Hiv Detection
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.3956
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00847865002745
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