Identity
- Trade Name
- PGDx elio diversiPhi EUDAMEDPGDx elio™ diversiPhi FDA UDI
- Generic Name
- Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- PGDx elio diversiPhi EUDAMED
- Model / Reference
- A0840101 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- A0840101 FDA UDI
- Primary DI / UDI-DI
- 00192721001241 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192721U0200400P3 EUDAMED
- Direct Marketing DI
- 00192721001241 EUDAMED
- FDA Product Code
- PFT FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3800 FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PGDx elio diversiPhi by Personal Genome Diagnostics, 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 | 0192721U0200400P3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Personal Genome Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000026862
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 593ba0c2-4a4a-49a1-b5a4-08b6a4931e27 61 fields · synced Jul 9, 2026
- FDA UDI 451b1812-a96e-4c5c-9bc2-9b02a56cbc9b 33 fields · synced May 30, 2026