Identity
- Trade Name
- Protein S Ac FDA UDI
- Generic Name
- Protein S IVD, kit, clotting FDA UDI
- Device Name
- Determination of the functional activity of protein S in human plasma FDA UDI
- Model / Reference
- 10445968 FDA UDI
- Description
- Determination of the functional activity of protein S in human plasma FDA UDI
Identifiers
- Catalog Number
- OPAP03 FDA UDI
- Primary DI / UDI-DI
- 00842768006678 FDA UDI
- 510(k) Number
- K022290 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Protein S IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7290 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: Protein S IVD, kit, clotting
Protein S Ac by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Protein S IVD, kit, clotting.
- ThromboTek PSe — R2 DIAGNOSTICS, INC. · Class II
- ACTICLOT PROTEIN S — Biomedica ADI Inc. · Class II
- STA® - Staclot® Protein S — DIAGNOSTICA STAGO, INC. · Class II
- Protein S Ac — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K022290 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 II | 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 501e0c16-82dd-401b-b2f7-1bdd68e32f72 37 fields · synced Jun 8, 2026