Quantum HDx

GUDID G225QHDX360

The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories.

Pathcom Systems Corporation

Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD

• Primary Device ID: G225QHDX360
• NIH Device Record Key: 1084541b-8bc2-4edd-81a1-398f15b4eeaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum HDx
• Version Model Number: QHD-X36
• Company DUNS: 845346506
• Company Name: Pathcom Systems Corporation
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G225QHDX360 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

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: 2022-05-09
• Device Publish Date: 2022-05-01

Devices Manufactured by Pathcom Systems Corporation

• G225SS1Z0 - Nova Aura: 2024-04-16 The Nova Aura Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sectio
• G225SS1N0 - Histostainer AT: 2022-06-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
• G225PATSS10 - MD Stainer: 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
• G225QHDX360 - Quantum HDx: 2022-05-09The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories.
• G225QHDX360 - Quantum HDx: 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
• G225QSSX370 - Quantum S2: 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
• G225SS10 - Slide Stainer: 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
• G225SS1B30 - Oncore Pro: 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
• G225SS1DBS0 - High Lighter: 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp