Dade® Actin® FS Activated PTT Reagent
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Dade® Actin® FS Activated PTT Reagent EUDAMEDFDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
- Device Name
- IVDR_27_MAR EB_C_PROF_REAG_Actin_FS EUDAMEDLiquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time FDA UDI
- Model / Reference
- 10445710 EUDAMEDFDA UDIIVDR_27_MAR EB_C_PROF_REAG_Actin_FS EUDAMED
- Description
- Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time FDA UDI
Identifiers
- Catalog Number
- B4218-100 FDA UDI
- Primary DI / UDI-DI
- 00842768003844 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900165V4 EUDAMED
- Unit of Use DI
- 00842768019562 EUDAMED
- 510(k) Number
- K811589 FDA UDI
- FDA Product Code
- GGW FDA UDI
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
- GMDN Term
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7925 FDA UDI
- Market of Registration
- Germany 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
No
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Activated partial thromboplastin time (APTT) IVD, reagent
Dade® Actin® FS Activated PTT Reagent by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Activated partial thromboplastin time (APTT) IVD, reagent.
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- QuikCoag APTT-EA — Biomedica Diagnostics Inc · Class II
- IDG/Sanzay — IDG/SANZAY Corporation · Class II
- 0.25 M Calcium Chloride — Helena Laboratories, Corp. · Class II
- QuikCoag APTT-EA — Biomedica Diagnostics Inc · Class II
- APTT-SA (Soluble Activator) Reagent Kit — Helena Laboratories, Corp. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Phospholin ES w/ Calcium Chloride — R2 DIAGNOSTICS, INC. · Class II
Cleared under the same submission
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI 604b2aad-7323-4e38-867e-7c8fe4e3c839 37 fields · synced Jul 8, 2026
- EUDAMED 3675fa94-c284-4bfe-95f0-30f740b17ae6 61 fields · synced Jul 8, 2026