Identity
- Trade Name
- STA® - C.K. Prest® EUDAMEDSTA® - C.K. Prest® 5 FDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, kit, clotting FDA UDI
- Device Name
- STA® - C.K. Prest® EUDAMED
- Model / Reference
- 00597 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450005974 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607450APTT0002R6 EUDAMED
- 510(k) Number
- K792048 FDA UDI
- FDA Product Code
- GGW FDA UDI
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
- GMDN Term
- Activated partial thromboplastin time (APTT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7925 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Activated partial thromboplastin time (APTT) IVD, kit, clotting
STA® - C.K. Prest® 5 by Diagnostica Stago, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Activated partial thromboplastin time (APTT) IVD, kit, clotting.
- TriniCLOT™ aPTT HS 3 mL — TCOAG IRELAND LIMITED · Class II
- TriniCLOT™ aPTT S 3 mL — TCOAG IRELAND LIMITED · Class II
- TriniCLOT™ Automated aPTT 6 mL — TCOAG IRELAND LIMITED · Class II
- TriniCLOT™ Automated aPTT 3 mL — TCOAG IRELAND LIMITED · Class II
- TriniCLOT™ aPTT HS 10 mL — TCOAG IRELAND LIMITED · Class II
- STA® - PTT A 5 — DIAGNOSTICA STAGO, INC. · Class II
- STA® - Cephascreen® 10 — DIAGNOSTICA STAGO, INC. · Class II
- PTT-LA — DIAGNOSTICA STAGO, INC. · Class II
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
- Diagnostica Stago, Inc.
Sources (2)
- FDA UDI f6506396-9774-44f5-aa4b-9e0d7bb7a939 34 fields · synced Jun 20, 2026
- EUDAMED 68c062a0-8473-4045-a403-e2fcf22a524b 61 fields · synced Jun 20, 2026