ANTI-TOXOPLASMA GONDII - PU125-5UP
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen.
Environmental Conditions
- Store at 2-8°C
Device Sizes
- Total Volume: 0.5 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MVU
Device Name: Reagents, Specific, Analyte
Device Class: 1
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: 864.4020
Third Party Flag: N
Medical Specialty: PA
Device IdentifiersDevice Id: 00810119674425
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