QUANTA Flash® MPO Reagents

Basic Information

• Brand Name: QUANTA Flash® MPO Reagents
• Primary DI: 08426950627685
• Version / Model: 701130
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-14
• Public Version: 1
• Public Version Date: 2023-12-22
• Public Version Status: New
• Public Device Record Key: 3048d1eb-32f5-4aec-9abb-8a0f97520a7e

Device Description

1. QUANTA Flash MPO Reagent Cartridge contains the following reagents for 100 determinations: a. MPO coated paramagnetic beads, in a liquid containing buffer, protein stabilizers and preservative. b. Assay Buffer – colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives. c. Tracer IgG– Isoluminol labeled anti-human IgG antibodies, containing buffer, protein stabilizers and preservative. d. Sample Dilution Buffer – colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59008	Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to myeloperoxidase (MPO) in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950627685	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112545	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius