Parsortix® PC1 system

Primary DI
05056364200094
Brand
Parsortix® PC1 system
Company
ANGLE PLC
Model
MBC-IVD-01-010-US
Device description
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.
Published
2024-04-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QSACirculating Tumor Cell (Ctc) Enrichment Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSACirculating Tumor Cell (Ctc) Enrichment DeviceImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200062000Parsortix PC1 DeviceAngle Europe , Ltd.2022-05-24QSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056364200094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056364200094050563642000945056364200094

GMDN Terms#

Term, Definition table
TermDefinition
Circulating tumour cell separation system cassette IVDA microfluidic chamber intended to be used onboard a circulating tumour cell separation instrument to collect and contain circulating tumour cells extracted from a whole blood specimen. It is typically made of synthetic polymer materials (e.g., plastic). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
737269212
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056364200070Parsortix® PC1 systemN/A2024-04-01
05056364200087Parsortix® PC1 systemPTX-PCI-IVD-US2024-04-01
05056364200100Parsortix® PC1 systemICT-IVD-01-010.B1-US2024-04-01
05056364200117Parsortix® PC1 systemICT-IVD-01-010.B2-US2024-04-01
05056364200124Parsortix® PC1 systemCAS-3P-IVD-652024-04-01
05056364200131Parsortix® PC1 systemCAS-3P-IVD-CC2024-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056364200070Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200087Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200100Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200117Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200124Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200131Parsortix® PC1 systemANGLE PLCQSA2024-04-01