IntelliPrep FFPE DNA Extraction Kit 83015

GUDID 04719882810268

The IntelliPrep FFPE DNA Extraction Kit is intended to be used only with the IntelliPrep TRIO 240 Sample Preparation System for automated nucleic acids purification from FFPE (Formalin-Fixed, Paraffin-Embedded) tissue samples. The product is intended to be used by trained and qualified laboratory users for molecular biology applications and is not intended for the diagnosis or treatment of a disease.

PlexBio Co., Ltd.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 04719882810268
• NIH Device Record Key: 89919fa3-84ed-4ecd-8523-b9303d2560ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliPrep FFPE DNA Extraction Kit
• Version Model Number: 83015
• Catalog Number: 83015
• Company DUNS: 656671356
• Company Name: PlexBio Co., Ltd.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram
• Weight: 2.03 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719882810268 [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: 2026-02-05 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: 2026-02-05The IntelliPrep FFPE DNA Extraction Kit is intended to be used only with the IntelliPrep TRIO 240 Sample Preparation System for automated nucleic acids purification from FFPE (Formalin-Fixed, Paraffin-Embedded) tissue samples. The product is intended to be used by trained and qualified laboratory users for molecular biology applications and is not intended for the diagnosis or treatment of a disease.
• 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