Parsortix® PC1 system

Primary DI
05056364200070
Brand
Parsortix® PC1 system
Company
ANGLE PLC
Model
N/A
Device description
IVD Parsortix® PC1 system, US
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

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
05056364200070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056364200070050563642000705056364200070

GMDN Terms#

Term, Definition table
TermDefinition
Circulating tumour cell separation system IVDA collection of devices including an electrically-powered laboratory instrument, microfluidic cassette and control materials, intended to be used to separate and collect circulating tumour cells of a specified size and/or deformity from a whole blood specimen using a mechanical separation method (e.g., microfluidics). The instrument channels the blood specimen through the microfluidic cassette, where the circulating tumour cells are concentrated and contained for subsequent in vitro diagnostic analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
737269212
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056364200087Parsortix® PC1 systemPTX-PCI-IVD-US2024-04-01
05056364200094Parsortix® PC1 systemMBC-IVD-01-010-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
05056364200087Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200094Parsortix® 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