Home GUDID 00855360006021
REAADS Protein C Test Kit
Primary DI 00855360006021
Brand REAADS Protein C Test Kit
Company CORGENIX MEDICAL CORPORATION
Model 035-001
Catalog number 035-001
Device description INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TESTProtein C deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. Patients with a congenital heterozygous deficiency may present with venous thrombosis in young adulthood, while patients with the rare homozygous deficiency present with massive thrombosis (purpura fulminans) during the neonatal period. The prevalence of Protein C deficiency in the general population has been estimated at 1 in 300. In younger patients (
Published 2016-05-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name GGP Test, Qualitative And Quantitative Factor Deficiency
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GGP Test, Qualitative And Quantitative Factor Deficiency Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00855360006021 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00855360006021 00855360006021 855360006021 0855360006021
GMDN Terms# Term, Definition table Term Definition Protein C IVD, kit, chromogenic A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein C in a clinical specimen, using a chromogenic method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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