Sonoclot® Reference Plasma Quality Control Kit 900-1318
GUDID B55890013181
The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements. Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation. Each Kit contains: 1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material. 1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water. 1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride. 5 plastic 1 ml syringes 2 non-activated test cuvettes (blue with clear caps, stir bars, and probes)
SIENCO, INC.
Multiple coagulation factor IVD, control| Primary Device ID | B55890013181 |
| NIH Device Record Key | 0d85fdcd-dbd2-4a97-948b-9f55b78bb5d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonoclot® Reference Plasma Quality Control Kit |
| Version Model Number | 900-1318 |
| Catalog Number | 900-1318 |
| Company DUNS | 064039514 |
| Company Name | SIENCO, INC. |
| Device Count | 1 |
| 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 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B55890013181 [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.
| B558DP29510 - Sonoclot® Coagulation & Platelet Function Analyzer | 2023-07-06 The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and plat |
| B55880004001 - Sonoclot® kACT Kit | 2021-07-27 The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT |
| B55880004010 - Sonoclot® kACT Kit | 2021-07-27 The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The k |
| B55880004250 - Sonoclot® NonActivated Kit | 2021-07-27 The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot |
| B55880004260 - Sonoclot® NonActivated Kit | 2021-07-27 The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot |
| 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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