Identity
- Trade Name
- IVD CAPSULE PSP FDA UDI
- Generic Name
- Pancreatic stone protein (PSP) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP). FDA UDI
- Model / Reference
- P02.00026 FDA UDI
- Description
- The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649996894021 FDA UDI
- FDA Product Code
- SCX FDA UDI
- GMDN Term
- Pancreatic stone protein (PSP) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3215 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: Pancreatic stone protein (PSP) IVD, kit, fluorescent immunoassay
Ivd Capsule Psp by Abionic SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Abionic SA
Sources (1)
- FDA UDI c4161c27-8416-4df0-9b85-766be13e3996 34 fields · synced May 30, 2026