VITROS Immunodiagnostic Products HIV Combo Controls (Anti
VITROS - 691 2265
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to the human immunodeficiency virus 1 (HIV1) in a clinical specimen.
Environmental Conditions
- Once opened, may be stored at 2–8 °C for up to 13 weeks or frozen (with no more than 7 freeze-thaw cycles) for up to 13 weeks
- 8.00
- 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: OHQ
Device Name: Multi-Analyte Controls Unassayed
Device Class: 1
Physical State: quality control material
Definition: A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: quality control material
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: in vitro diagnostic
Regulation Number: 862.1660
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 10758750033195
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
Device Id: 20758750033192
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10758750033195
Package Quantity: 30
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case