Identity
- Trade Name
- STA® - Stachrom® Plasminogen EUDAMEDFDA UDI
- Generic Name
- Plasminogen IVD, kit, chromogenic FDA UDI
- Device Name
- STA® - Stachrom® Plasminogen EUDAMED
- Model / Reference
- 00658 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450006582 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03607450006582 EUDAMED
- 510(k) Number
- K832591 FDA UDI
- FDA Product Code
- DDX FDA UDI
- EMDN Code
- W0103020505 PLASMINOGEN EUDAMED
- GMDN Term
- Plasminogen IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5715 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
Yes
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
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
Yes
FDA UDI
Category: Plasminogen IVD, kit, chromogenic
STA® - Stachrom® Plasminogen by Diagnostica Stago, Inc. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Plasminogen IVD, kit, chromogenic.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostica Stago, Inc.
Sources (2)
- FDA UDI 41324679-3415-45a3-b70e-b38eb65ee925 34 fields · synced Jun 19, 2026
- EUDAMED 8bc4b284-48d2-487b-8ea6-0d243c4e0e13 61 fields · synced Jun 19, 2026