PAXgene® Blood RNA Tube 762165

GUDID 54053727621653

PAXgene® Blood RNA Tube

PreAnalytiX GmbH

Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer Evacuated blood collection tube IVD, nucleic acid stabilizer

• Primary Device ID: 54053727621653
• NIH Device Record Key: 07165ec7-f598-413f-9e9f-5ea6ce8eaf03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAXgene® Blood RNA Tube
• Version Model Number: 762165
• Catalog Number: 762165
• Company DUNS: 480915029
• Company Name: PreAnalytiX GmbH
• Device Count: 100
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053727621658 [Unit of Use]
GS1	54053727621653 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-25

Devices Manufactured by PreAnalytiX GmbH

• 04053727611659 - PAXgene® Blood DNA Tube: 2023-11-09 PAX DNA IVD BLOOD COLLECTION TUBE
• 54053727621653 - PAXgene® Blood RNA Tube: 2018-07-06PAXgene® Blood RNA 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