FDA.reportPublic FDA data

Parsortix® PC1 system

Primary DI
05056364200100
Brand
Parsortix® PC1 system
Company
ANGLE PLC
Model
ICT-IVD-01-010.B1-US
Device description
Parsortix® PC1 Instrument Control Test Kit, US, Box 1 (cold storage 2-8 °C) containing 10XICT-01 Instrument Control Test (ICT) tubes (cold chain)
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
05056364200100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056364200100050563642001005056364200100

GMDN Terms#

Term, Definition table
TermDefinition
Circulating tumour cell separation system control IVDAn aliquoted cell suspension intended to be used to verify the performance of a circulating tumour cell separation instrument. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
05056364200094Parsortix® PC1 systemMBC-IVD-01-010-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
05056364200094Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200117Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200124Parsortix® PC1 systemANGLE PLCQSA2024-04-01
05056364200131Parsortix® PC1 systemANGLE PLCQSA2024-04-01