Parsortix® PC1 system

GUDID 05056364200100

Parsortix® PC1 Instrument Control Test Kit, US, Box 1 (cold storage 2-8 °C) containing 10XICT-01 Instrument Control Test (ICT) tubes (cold chain)

ANGLE PLC

Circulating tumour cell separation system control IVD

• Primary Device ID: 05056364200100
• NIH Device Record Key: dc6aa8d0-9854-43ab-890b-1fe1c0b0a044
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parsortix® PC1 system
• Version Model Number: ICT-IVD-01-010.B1-US
• Company DUNS: 737269212
• Company Name: ANGLE PLC
• 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056364200100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200062

FDA Product Code

• QSA: Circulating Tumor Cell (Ctc) Enrichment Device

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: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [Parsortix® PC1 system]

• 05056364200131: Parsortix® PC1 GEN3C Cleaning Cassette
• 05056364200124: Parsortix® PC1 GEN3P6.5IVD cell separation cassette
• 05056364200117: Parsortix® PC1 Instrument Control Test Kit, US, Box 2 (Ambient) containing 10X12mL sample tubes
• 05056364200100: Parsortix® PC1 Instrument Control Test Kit, US, Box 1 (cold storage 2-8 °C) containing 10XICT-
• 05056364200094: Parsortix® PC1 Metastatic Breast Cancer Kit, US containing 10XParsortix PC1 GEN3P6.5IVD Cell Se
• 05056364200087: Parsortix PC1 instrument pre-loaded with the application software and provided with accessories.
• 05056364200070: IVD Parsortix® PC1 system, US