Identity
- Trade Name
- STA® - PTT A 5 FDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, kit, clotting FDA UDI
- Model / Reference
- 00595 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 13607450005957 FDA UDI
- 510(k) Number
- K861190 FDA UDI
- FDA Product Code
- GGW FDA UDI
- GMDN Term
- Activated partial thromboplastin time (APTT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7925 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
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: Activated partial thromboplastin time (APTT) IVD, kit, clotting
Sta® - Ptt A 5 by Diagnostica Stago, Inc. — Class II — FDA UDI — listed in FDA GUDID — 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® - C.K. Prest® 5 — DIAGNOSTICA STAGO, INC. · Class II
- STA® - Cephascreen® 10 — DIAGNOSTICA STAGO, INC. · Class II
- PTT-LA — DIAGNOSTICA STAGO, INC. · Class II
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
- Diagnostica Stago, Inc.
Sources (1)
- FDA UDI 64df2e51-c20e-4659-b35b-696df6652eda 34 fields · synced May 30, 2026