QUANTA Flash® B2GP1-Domain 1Reagents

GUDID 08426950601951

1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet 4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 1 5. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2

INOVA DIAGNOSTICS, INC.

Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 08426950601951
• NIH Device Record Key: bf68a67b-f918-41b7-9649-dc5e0144b02c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA Flash® B2GP1-Domain 1Reagents
• Version Model Number: 701188
• Company DUNS: 188354831
• Company Name: INOVA DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-545-9495
• Email: support@inovadx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950601951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152875

FDA Product Code

• MSV: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-10-10
• Device Publish Date: 2016-08-31

Devices Manufactured by INOVA DIAGNOSTICS, INC.

• 08426950506355 - QUANTA Lite® Chromatin ELISA: 2024-11-07 1. 1x Chromatin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL p
• 00195126000871 - Aptiva® System Cleaning Solution Kit: 2024-03-26 The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module
• 00195126000741 - Aptiva® Instrument System Cuvettes: 2024-03-19 The Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument Syste
• 08426950865094 - QUANTA-Lyser® 3000 ELISA/IFA: 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie
• 08426950865100 - QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator: 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie
• 08426950865131 - QUANTA-Lyser® 3000 /IFA: 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie
• 08426951307227 - Aptiva® Multi-Analyte Instrument: 2024-03-19 Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The sy
• 08430793040716 - Aptiva® APS IgG Reagent: 2024-03-19 1. Aptiva APS IgG Reagent Cartridge -APS IgG Beads (1x0.5mL) -Assay Buffer (1x17mL) -PE Tracer IgG(1x17mL) -Rehydration Buffer (