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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGPTest, Qualitative And Quantitative Factor Deficiency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGPTest, Qualitative And Quantitative Factor DeficiencyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972342000REAADS PROTEIN C ANTIGEN TEST KITReaads Medical Products, Inc.1997-10-06GGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855360006021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855360006021008553600060218553600060210855360006021

GMDN Terms#

Term, Definition table
TermDefinition
Protein C IVD, kit, chromogenicA 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
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-729-5661technicalsupport@corgenix.com

Regulatory Flags#

DUNS number
619834542
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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