Identity
- Trade Name
- ProciseDx Analyzer EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- ProciseDx Analyzer EUDAMEDThe ProciseDx Analyzer is intended for use with Procise assay cartridges manufactured by ProciseDx Inc. for the in vitro diagnosis and quantification of various targets or conditions in human patients. The ProciseDx Analyzer should be used in accordance with user documentation and facility specific regulations. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 4390 EUDAMEDFDA UDI
- Description
- The ProciseDx Analyzer is intended for use with Procise assay cartridges manufactured by ProciseDx Inc. for the in vitro diagnosis and quantification of various targets or conditions in human patients. The ProciseDx Analyzer should be used in accordance with user documentation and facility specific regulations. For in vitro diagnostic use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08100322943909 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003229PDXA439022SS EUDAMED
- Direct Marketing DI
- 08100322943909 EUDAMED
- FDA Product Code
- DCK FDA UDI
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5270 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ProciseDx Analyzer by ProciseDx Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081003229PDXA439022SS | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- ProciseDx Inc.
- EUDAMED SRN
- US-MF-000040747
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED f4ed80de-1f08-4a72-a1ce-b081ecd42bd4 61 fields · synced May 30, 2026
- FDA UDI 654cf0ba-1d0c-42d8-9fdb-cd1a2e59729c 34 fields · synced May 30, 2026