Protein S Ac
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Protein S Ac EUDAMEDFDA UDI
- Generic Name
- Protein S IVD, kit, clotting FDA UDI
- Device Name
- IVDR_27_MAR EB_C_KIT_Prot_S_Ac EUDAMEDDetermination of the functional activity of protein S in human plasma FDA UDI
- Model / Reference
- 10873846 EUDAMEDFDA UDIIVDR_27_MAR EB_C_KIT_Prot_S_Ac EUDAMED
- Description
- Determination of the functional activity of protein S in human plasma FDA UDI
Identifiers
- Catalog Number
- 10873846 FDA UDI
- Primary DI / UDI-DI
- 00630414640457 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900968WJ EUDAMED
- 510(k) Number
- K022290 FDA UDI
- FDA Product Code
- GGP FDA UDI
- EMDN Code
- W0103020608 PROTEIN S ACTIVITY EUDAMED
- GMDN Term
- Protein S IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Protein S IVD, kit, clotting
Protein S Ac by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI 3aa2fd20-8482-4335-a447-61a832446d48 37 fields · synced Aug 1, 2026
- EUDAMED a4c4193a-4fc3-4dde-8c3e-45417621ccb7 61 fields · synced Aug 1, 2026