PAXgene® Blood RNA Tube 762165

GUDID 54053727621653

PAXgene® Blood RNA Tube

PreAnalytiX GmbH

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

On-Brand Devices [PAXgene® Blood RNA Tube]

• 54053727621653: PAXgene® Blood RNA Tube
• 04053727621658: TUBE RNA PLH 16X100 2.5 PLBLCE CLR