Identity
- Trade Name
- ThromboTek PSe EUDAMEDFDA UDI
- Generic Name
- Protein S IVD, kit, clotting FDA UDI
- Device Name
- ThromboTek PSe EUDAMEDProtein S Kit 80-160 DET FDA UDI
- Model / Reference
- 90-480 EUDAMEDFDA UDI
- Description
- Protein S Kit 80-160 DET FDA UDI
Identifiers
- Catalog Number
- 90-480 FDA UDI
- Primary DI / UDI-DI
- 00859394006095 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00859394006095 EUDAMED
- 510(k) Number
- K082631 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 IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
No
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
No
FDA UDI
Category: Protein S IVD, kit, clotting
ThromboTek PSe by R2 Diagnostics, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Protein S IVD, kit, clotting.
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (2)
- FDA UDI b6240e4b-d734-4b7c-9ab1-09cc86699fcb 35 fields · synced Jul 12, 2026
- EUDAMED acaf83f4-978a-4cdc-8a41-c8ddf7cc2556 61 fields · synced Jul 12, 2026