FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Parsortix® PC1 system
DI: 05056364200131
·
Model: CAS-3P-IVD-CC
·
ANGLE PLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Parsortix® PC1 system
- Primary DI
- 05056364200131
- Version / Model
- CAS-3P-IVD-CC
- 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
- c6f9c007-1ec1-4616-9d8f-b68cf53ac62e
- Distribution End Date
- 2025-12-22
Device Description
Parsortix® PC1 GEN3C Cleaning Cassette
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 |
|---|---|---|---|---|
| 66503 | Circulating tumour cell separation system control IVD | An aliquoted cell suspension intended to be used to verify the performance of a circulating tumour cell separation instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056364200131 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200062 | 000 |