Identity
- Trade Name
- Berichrom Plasminogen FDA UDI
- Generic Name
- Plasminogen IVD, kit, chromogenic FDA UDI
- Device Name
- Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders FDA UDI
- Model / Reference
- 10873885 FDA UDI
- Description
- Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders FDA UDI
Identifiers
- Catalog Number
- 10873885 FDA UDI
- Primary DI / UDI-DI
- 00630414639352 FDA UDI
- 510(k) Number
- K884766 FDA UDI
- FDA Product Code
- DDX FDA UDI
- GMDN Term
- Plasminogen IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5715 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Plasminogen IVD, kit, chromogenic
Berichrom Plasminogen by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plasminogen IVD, kit, chromogenic.
Cleared under the same submission
K884766 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI f9d4fc70-4c2f-4655-9fdb-7918ac4862df 37 fields · synced May 30, 2026