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The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The instrument utilizes photo-optical principles for clot detection. The light source is a high intensity photodiode. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, 4 reagent and 4 cuvette pre-warming positions.

The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.

The Coagulation Control Levels 1, 2 and 3 are lyophilized preparations of citrated plasma obtained from healthy donors, which are adjusted to yield prolonged PT and APTT values. Prior to lyophilization buffer and a stabilizer are added. The bulk plasma is tested using an FDA approved method for HBsAG, HIV antibodies and HCV antibodies and is certified for negativity for each batch.

The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers. The Vital Scientific PT with Calcium is an in-vitro diagnostic reagent intended for use for the performance of one-stage Prothrombin Time (PT) Testing and assays which are based on a modified prothrombin time.

The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

This notification is for an in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

A random access, automated Clinical Micro-Chemistry Analyzer with a throughput of up to 180 test per hour which is intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry. monitoring drugs of abuse and in therapeutic drug monitoring.