Identity
- Trade Name
- Dade Actin FS Activated PTT Reagent FDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
- Device Name
- Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time FDA UDI
- Model / Reference
- 10873828 FDA UDI
- Description
- Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time FDA UDI
Identifiers
- Catalog Number
- 10873828 FDA UDI
- Primary DI / UDI-DI
- 00630414640327 FDA UDI
- 510(k) Number
- K811589 FDA UDI
- FDA Product Code
- GGW FDA UDI
- GMDN Term
- Activated partial thromboplastin time (APTT) IVD, reagent 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Activated partial thromboplastin time (APTT) IVD, reagent
Dade Actin FS Activated PTT Reagent by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 (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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI bf1629b1-b046-4515-a937-33982df2b17d 37 fields · synced Jun 8, 2026