Identity
- Trade Name
- Asserachrom® Total Protein S EUDAMEDFDA UDI
- Generic Name
- Protein S IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Asserachrom® Total Protein S EUDAMED
- Model / Reference
- 00945 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450009453 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03607450009453 EUDAMED
- 510(k) Number
- K954040 FDA UDI
- FDA Product Code
- GGP FDA UDI
- EMDN Code
- W0103020613 TOTAL PROTEIN S ANTIGEN EUDAMED
- GMDN Term
- Protein S IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Yes
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
Yes
FDA UDI
Category: Protein S IVD, kit, enzyme immunoassay (EIA)
Asserachrom® Total Protein S by Diagnostica Stago, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Protein S IVD, kit, enzyme immunoassay (EIA).
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- Protein S Antigen Rocket Kit — Helena Laboratories, Corp. · Class II
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
- Diagnostica Stago, Inc.
Sources (2)
- FDA UDI 789aaab5-3edd-45c9-8b39-aa6bb5fe58d3 34 fields · synced Jul 26, 2026
- EUDAMED 74d3703e-42b5-411d-af5e-836cc8d20b59 61 fields · synced Jul 26, 2026