Sonoclot® Reference Plasma Quality Control Kit - The Reference Plasma Quality Control Kit is for - SIENCO, INC.

Duns Number:064039514

Device Description: The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to 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 syringes2 non-activated test cuvettes (blue with clear caps, stir bars, and probes)

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More Product Details

Catalog Number

900-1318

Brand Name

Sonoclot® Reference Plasma Quality Control Kit

Version/Model Number

900-1318

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K952560

Product Code Details

Product Code

JPA

Product Code Name

System, Multipurpose For In Vitro Coagulation Studies

Device Record Status

Public Device Record Key

0d85fdcd-dbd2-4a97-948b-9f55b78bb5d7

Public Version Date

July 27, 2021

Public Version Number

1

DI Record Publish Date

July 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIENCO, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11