Parsortix® PC1 system

GUDID 05056364200094

Parsortix® PC1 Metastatic Breast Cancer Kit, US containing 10XParsortix PC1 GEN3P6.5IVD Cell Separation Cassettes, 1XParsortix PC1 GEN3C Cleaning Cassettes, 10XSample label sets, 1Xpackage insert (per kit) containing instructions for use and expected performance data for the Parsortix PC1 instrument, when used in conjunction with the Parsortix PC1 MBC-01 Metastatic Breast Cancer Kit.

ANGLE PLC

Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD Circulating tumour cell separation system cassette IVD

• Primary Device ID: 05056364200094
• NIH Device Record Key: aad53dfe-f9ca-47e0-95d2-a9cf6b9503bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parsortix® PC1 system
• Version Model Number: MBC-IVD-01-010-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056364200094 [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