QUANTIMETRIX CORPORATION

Address:2005 Manhattan Beach Blvd,REDONDO BEACH,CA,90278,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Biuret (Colorimetric), Total Protein (CEK) (2)

Premarket Exempt

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QuanTtest Human Protein Standards Set - M0513410021 Catalog Number : 3410-02

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

Product Code : CEK

Prescription Use : No

Device Count : 1

QuanTtest Red Pyrogallol Red Reagent - M0515210120 Catalog Number : 5210-12

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.