Address:2005 Manhattan Beach Blvd,REDONDO BEACH,CA,90278,US
Device Description : The Pediatric Bilirubin Control is intended as a means of monitoring various bil The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added.
Device Class :
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No
Device Description : The Liposure Lipoprotein Control is intended for monitoring lipoprotein fraction The Liposure Lipoprotein Control is intended for monitoring lipoprotein fractions (VLDL to HDL) as well as subfractions (Mid-bands, LDL subfractions 1, 2, and 3) using the Lipoprint LDL System to validate the separation and quantitation of lipoproteins in patient serum samples. It is prepared from human serum and supplied lyophilized. The lyophilized material contains stabilizers and preservatives.
Device Class : 1
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No
Device Description : The Lipoprint System Buffer is intended to be used as an electrolyte buffer solu The Lipoprint System Buffer is intended to be used as an electrolyte buffer solution in conjunction with Quantimetrix Lipoprint LDL and HDL reagent kits. It is a mixture of Tris (hydroxymethyl) aminomethane and Boric Acid crystals.
Device Class : 1
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No
Device Description : The Lipoprint System LDL Subfractions Kit is a device intended to measure lipopr The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation.
Device Class : 1
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No
Device Description : QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyro QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.
Device Class : 2
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No
Device Description : QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl.
Device Class : 2
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No
Device Description : The Dipper POCT is a two level urinalysis dipstick control. Each level is contai The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert.
Device Class :
Duns Number: 010717890
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Dipper POCT is a two level urinalysis dipstick control. Each level is contai The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert.
Device Class :
Duns Number: 010717890
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed methods, and as a control for confirmatory tests. It is also intended as a means of validating the processing and centrifugation of patient urine samples prior to microscopic evaluation of urine sediment. The controls are supplied liquid, ready-to-use in two levels. They do not require reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, and other compounds have been added to produce the desired reactions when tested by methods described in the product insert.
Device Class : 1
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No
Device Description : The quanTtest red Total Protein Assay System is intended for the quantitative de The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL).
Device Class : 2
Duns Number: 010717890
Premarket Exempt : No
Prescription Use : No