Aptiva® Instrument System Cuvettes

GUDID 00195126000741

The Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument System Cuvettes are for single use as a reaction or dilution container in the Aptiva Multi-Analyte Instrument. Instrument System Cuvettes are required to ensure the functionality and performance of the Aptiva Multi-Analyte Instrument. Use of alternate cuvettes can negatively impact Aptiva Multi-Analyte Instrument results.

INOVA DIAGNOSTICS, INC.

Laboratory analyser cuvette IVD, single-use

• Primary Device ID: 00195126000741
• NIH Device Record Key: 7ff1983f-fa04-4b0e-ae70-4e858309ff44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptiva® Instrument System Cuvettes
• Version Model Number: AC1005
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	00195126000741 [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.

• 08426950454373 - QUANTA Lite® ANA ELISA: 2026-02-09 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL predilu
• 08426950456193 - NOVA Lite® HEp-2 ANA Kit: 2026-02-09 1. 20x Hep- 2 ANA Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate
• 08426950593461 - NOVA Lite® HEp-2 ANA Kit: 2026-02-09 1. 5 x 12-well HEp-2 Substrate Slides 2. 1 x 4mL FITC Anti-Human IgG Conjugate 3. 1 x 0.5 mL ANA Titratable Endpoint Pattern Con
• 08426950593577 - NOVA Lite® ANA Kit with DAPI: 2026-02-09 1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI
• 08426950594208 - NOVA Lite® HEp-2 External EB Kits: 2026-02-09 1. 20x 12-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x 1 mL Centromere Positive Con
• 08426950594857 - NOVA Lite® Auto AB Panel: 2026-02-09 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centr
• 08426950595267 - NOVA Lite® HEp-2 External EB Kits: 2026-02-09 1. 10x 6-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x mL Centromere Positive Contr
• 08426950627692 - QUANTA Flash PR3 Reagents: 2024-12-23 1. QUANTA Flash PR3 Reagent Cartridge