Identity
- Trade Name
- UroVysion FDA UDI
- Generic Name
- Bladder tumour-associated mutation IVD, probe FDA UDI
- Device Name
- UroVysion Bladder Cancer Kit FDA UDI
- Model / Reference
- 02J27-095 FDA UDI
- Description
- UroVysion Bladder Cancer Kit FDA UDI
Identifiers
- Catalog Number
- 02J27-095 FDA UDI
- Primary DI / UDI-DI
- 00884999002180 FDA UDI
- PMA Number
- P030052 FDA UDI
- FDA Product Code
- NSD FDA UDI
- GMDN Term
- Bladder tumour-associated mutation IVD, probe FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bladder tumour-associated mutation IVD, probe
UroVysion by Abbott Molecular — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bladder tumour-associated mutation IVD, probe.
- UroVysion — Abbott Molecular · Class III
Cleared under the same submission
P030052 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI 5e51d3b0-4700-49b8-b69e-4ee77f1dcfdd 37 fields · synced Jun 1, 2026