iQ® Body Fluids Controls
iQ®200 - iQ® Body Fluids Controls-Level I and Level II (NA/INTL)
Device Description
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.
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: JPK
Device Name: Mixture, Hematology Quality Control
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
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: 864.8625
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 10837461002345
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