FDA UDI
In Commercial Distribution
🇺🇸 United States
PhenoMATRIX
DI: 58059796360857
·
Model: WLAB-PHENOMATRIX
·
COPAN WASP SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PhenoMATRIX
- Primary DI
- 58059796360857
- Version / Model
- WLAB-PHENOMATRIX
- Catalog Number
- WLAB-PHENOMATRIX
- Company Name
- COPAN WASP SRL
- Labeler DUNS
- 434263590
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-13
- Public Version
- 1
- Public Version Date
- 2026-02-23
- Public Version Status
- New
- Public Device Record Key
- abe52470-3b64-4f9f-a74f-69e30e32362a
Device Description
PhenoMATRIX
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPU | Microbial Colony Image Assessment System | Microbiology | 866.2190 | 2 |
| QQY | Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms | Microbiology | 866.2190 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58721 | Histology/cytology/microbiology image-analysis interpretive software IVD | An interpretive software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology or microbiology laboratory to assist in the analysis of clinical specimens (e.g., biopsy, blood smear, urine) and/or microbial cultures for the quantitative/qualitative detection of cell markers (e.g., hormone receptors), changes in tissue architecture and/or cell morphological/physiological characteristics [e.g., nucleus size, cytoplasmic granularity, rate of cell division], and/or infectious microorganisms associated with a disease (e.g., breast cancer, malaria, UTI). Results are also interpreted by a clinician to guide patient management. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 58059796360857 | GS1 |
Customer Contacts
- Phone
- +390302687218
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251511 | 000 |