Identity
- Trade Name
- INNOVANCE Free PS Ag FDA UDI
- Generic Name
- Protein S IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer. FDA UDI
- Model / Reference
- 10873458 FDA UDI
- Description
- For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer. FDA UDI
Identifiers
- Catalog Number
- OPGL07 FDA UDI
- Primary DI / UDI-DI
- 00842768039522 FDA UDI
- 510(k) Number
- K181525 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Protein S IVD, kit, nephelometry/turbidimetry 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, nephelometry/turbidimetry
INNOVANCE Free PS Ag 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, nephelometry/turbidimetry.
- Liatest® Protein S — DIAGNOSTICA STAGO, INC. · Class II
- INNOVANCE Free PS Ag — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K181525 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 4788a1ee-1074-4921-a8df-855513354ca3 37 fields · synced May 30, 2026