Sonoclot® aiACT Kit
Basic Information
- Brand Name
- Sonoclot® aiACT Kit
- Primary DI
- B55880004421
- Version / Model
- 800-0442
- Catalog Number
- 800-0442
- Company Name
- SIENCO, INC.
- Labeler DUNS
- 064039514
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-07-19
- Public Version
- 1
- Public Version Date
- 2021-07-27
- Public Version Status
- New
- Public Device Record Key
- f1e7196b-d610-4232-8b6d-cf7d3587c92b
Device Description
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 100 lidded yellow plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JBP | Activated Whole Blood Clotting Time | Hematology | 864.7140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55996 | Multiple coagulation factor IVD, kit, clotting | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B55880004420 | HIBCC | ||||
| Primary | B55880004421 | HIBCC |
Customer Contacts
- Phone
- 303-420-1148
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032952 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius