FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Parsortix® PC1 system
DI: 05056364200094
·
Model: MBC-IVD-01-010-US
·
ANGLE PLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Parsortix® PC1 system
- Primary DI
- 05056364200094
- Version / Model
- MBC-IVD-01-010-US
- Company Name
- ANGLE PLC
- Labeler DUNS
- 737269212
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-01
- Public Version
- 2
- Public Version Date
- 2025-12-23
- Public Version Status
- Update
- Public Device Record Key
- aad53dfe-f9ca-47e0-95d2-a9cf6b9503bb
- Distribution End Date
- 2025-12-22
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QSA | Circulating Tumor Cell (Ctc) Enrichment Device | Immunology | 866.6110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66504 | Circulating tumour cell separation system cassette IVD | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056364200094 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200062 | 000 |