Aptiva® Multi-Analyte Instrument

GUDID 08426951307227

Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The system is based on digital capture of high-resolution images of the paramagnetic particles to determine the analytes in samples

INOVA DIAGNOSTICS, INC.

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• Primary Device ID: 08426951307227
• NIH Device Record Key: dc82f454-8d1c-4138-8ee4-37ea5f1e89e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptiva® Multi-Analyte Instrument
• Version Model Number: AP5000
• Company DUNS: 188354831
• Company Name: INOVA DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426951307227 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by INOVA DIAGNOSTICS, INC.

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• 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: 2024-03-19Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The system is based on digital capture of high-resolution images of the paramagnetic particles to determine the analytes in samples
• 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 (
• 08430793040761 - Aptiva® APS IgG Calibrators: 2024-03-19 1.Aptiva APS IgG Calibrator 1 (2x0.3mL) 2. Aptiva APS IgG Calibrator 2 (2x0.3mL) 3. Aptiva APS IgG Calibrator 3 (2x0.3mL)