IntelliPrep TRIO 240 Sample Preparation System 80042

GUDID 04719882810046

The IntelliPrep TRIO 240 Sample Preparation System is designed for the combination use with dedicated IntelliPrep extraction kits to perform automated nucleic acids purification for assay setup. The extracted nucleic acids are intended for downstream molecular biology applications, not directly for the diagnosis, prevention, or treatment of a disease. The IntelliPrep TRIO 240 Sample Preparation System should be used by trained laboratory operators. The downstream diagnostic results obtained by using the extracted nucleic acid with this system should be interpreted in conjunction with clinical or laboratory data accordingly.

PlexBio Co., Ltd.

Nucleic acid sample preparation instrument IVD

• Primary Device ID: 04719882810046
• NIH Device Record Key: 5d6c29d6-a513-48cd-9039-b5f850133c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliPrep TRIO 240 Sample Preparation System
• Version Model Number: 80042
• Catalog Number: 80042
• Company DUNS: 656671356
• Company Name: PlexBio Co., Ltd.
• 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: 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 Dimensions

• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram
• Weight: 133 Kilogram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *-10°C-55°C/ 10-80% RH non-condensing

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719882810046 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2026-02-05
• Device Publish Date: 2026-01-28

Devices Manufactured by PlexBio Co., Ltd.

• 04719882810046 - IntelliPrep TRIO 240 Sample Preparation System: 2026-02-05The IntelliPrep TRIO 240 Sample Preparation System is designed for the combination use with dedicated IntelliPrep extraction kits to perform automated nucleic acids purification for assay setup. The extracted nucleic acids are intended for downstream molecular biology applications, not directly for the diagnosis, prevention, or treatment of a disease. The IntelliPrep TRIO 240 Sample Preparation System should be used by trained laboratory operators. The downstream diagnostic results obtained by using the extracted nucleic acid with this system should be interpreted in conjunction with clinical or laboratory data accordingly.
• 04719882810046 - IntelliPrep TRIO 240 Sample Preparation System: 2026-02-05 The IntelliPrep TRIO 240 Sample Preparation System is designed for the combination use with dedicated IntelliPrep extraction kit
• 04719882810237 - IntelliPrep Blood Genomic DNA Extraction Kit: 2026-02-05 The IntelliPrep Blood Genomic DNA Extraction Kit is intended to be used only with the IntelliPrep TRIO 240 Sample Preparation Sy
• 04719882810268 - IntelliPrep FFPE DNA Extraction Kit: 2026-02-05 The IntelliPrep FFPE DNA Extraction Kit is intended to be used only with the IntelliPrep TRIO 240 Sample Preparation System for
• 04719882810282 - IntelliPrep FFPE RNA Extraction Kit: 2026-02-05 The IntelliPrep FFPE RNA Extraction Kit is intended to be used only with the IntelliPrep TRIO 240 Sample Preparation System for
• 04719882810299 - IntelliPrep cfDNA Extraction Kit: 2026-02-05 The IntelliPrep cfDNA Extraction Kit is intended to be used only with the IntelliPrep TRIO 240 Sample Preparation System for aut