NOVA View® AUTOLoader

GUDID 08426950643708

The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction.

INOVA DIAGNOSTICS, INC.

Cell morphology analyser IVD, automated/semi-automated

• Primary Device ID: 08426950643708
• NIH Device Record Key: 9d52307e-7f27-470a-97ef-a3d045ffed46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA View® AUTOLoader
• Version Model Number: ALDR1000
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950643708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140039

FDA Product Code

• PIV: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

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: 2022-09-16
• Device Publish Date: 2016-08-31

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