Sonoclot® Reference Viscosity Oil Quality Control Kit 900-1302
GUDID B55890013020
The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer. This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation. The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution. Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer.
SIENCO, INC.
Multiple coagulation factor IVD, control| Primary Device ID | B55890013020 |
| NIH Device Record Key | 968ecf46-feee-4a55-918e-fb3c49c65ad9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonoclot® Reference Viscosity Oil Quality Control Kit |
| Version Model Number | 900-1302 |
| Catalog Number | 900-1302 |
| Company DUNS | 064039514 |
| Company Name | SIENCO, INC. |
| Device Count | 24 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 303-420-1148 |
| info@sienco.com | |
| Phone | 303-420-1148 |
| info@sienco.com | |
| Phone | 303-420-1148 |
| info@sienco.com | |
| Phone | 303-420-1148 |
| info@sienco.com | |
| Phone | 303-420-1148 |
| info@sienco.com | |
| Phone | 303-420-1148 |
| info@sienco.com | |
| Phone | 303-420-1148 |
| info@sienco.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B55890013020 [Unit of Use] |
| HIBCC | B55890013021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K952560
FDA Product Code
| JPA | System, Multipurpose For In Vitro Coagulation Studies |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-27 |
| Device Publish Date | 2021-07-19 |
Devices Manufactured by SIENCO, INC.
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| B55880004310 - Sonoclot® SonACT Kit | 2021-07-27 The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. T |
| B55880004320 - Sonoclot® SonACT Kit | 2021-07-27 The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. T |
| B55880004410 - Sonoclot® aiACT Kit | 2021-07-27 The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The a |
Trademark Results [Sonoclot]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONOCLOT 85825814 4388109 Live/Registered |
Sienco, Incorporated 2013-01-17 |
 SONOCLOT 73040018 1039577 Dead/Expired |
SIMONS, SANFORD L. 1974-12-20 |
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