PAXgene® Blood RNA Kit 762164

GUDID 04053727000149

The PAXgene® Blood RNA Kit isolates and purifies RNA from blood collected in a PAXgene® Blood RNA Tube.

PreAnalytiX GmbH

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 04053727000149
• NIH Device Record Key: 5613af38-5f7b-4250-8732-42d0e77c68a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAXgene® Blood RNA Kit
• Version Model Number: Version 2
• Catalog Number: 762164
• Company DUNS: 480915029
• Company Name: PreAnalytiX GmbH
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053727000149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082150

FDA Product Code

• NTW: System, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test

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: 2025-03-06
• Device Publish Date: 2025-02-26

Devices Manufactured by PreAnalytiX GmbH

• 04053727000149 - PAXgene® Blood RNA Kit: 2025-03-06The PAXgene® Blood RNA Kit isolates and purifies RNA from blood collected in a PAXgene® Blood RNA Tube.
• 04053727000149 - PAXgene® Blood RNA Kit: 2025-03-06 The PAXgene® Blood RNA Kit isolates and purifies RNA from blood collected in a PAXgene® Blood RNA Tube.
• 04053727621658 - PAXgene® Blood RNA Tube: 2024-07-16 TUBE RNA PLH 16X100 2.5 PLBLCE CLR
• 04053727611659 - PAXgene® Blood DNA Tube: 2023-11-09 PAX DNA IVD BLOOD COLLECTION TUBE
• 54053727621653 - PAXgene® Blood RNA Tube: 2018-07-06 PAXgene® Blood RNA Tube
• 54053727611654 - PAXgene® Blood DNA Tube: 2018-03-29 PAXgene® Blood DNA Tube