BioPlex 2200 Syphilis Total & RPR Calibrator Set
BioPlex 2200 - 12000651
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 quantitative detection of immunoglobulin G (IgG) antibodies to Treponema pallidum bacteria in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- Total Volume: 0.5 Milliliter
- 5 Vials
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JIT
Device Name: Calibrator, Secondary
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.1150
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 03610520652770
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