REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well) 038-001

GUDID 00855360006168

INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use. SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert.

CORGENIX MEDICAL CORPORATION

Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00855360006168
NIH Device Record Keydbc166ee-4a2c-4581-985a-c5e82d3365a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameREAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well)
Version Model Number038-001
Catalog Number038-001
Company DUNS619834542
Company NameCORGENIX MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-729-5661
Emailtechnicalsupport@corgenix.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855360006168 [Primary]

FDA Product Code

MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-14

Devices Manufactured by CORGENIX MEDICAL CORPORATION

00855360006007 - REAADS Protein S Antigen Test kit2018-07-06 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen
00855360006014 - REAADS Monoclonal Free Protein S Antigen2018-07-06 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrat
00855360006021 - REAADS Protein C Test Kit2018-07-06 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated hu
00855360006038 - REAADS von Willebrand Factor Antigen Test Kit2018-07-06 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Antigen (V
00855360006069 - Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well)2018-07-06 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythema
00855360006076 - Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well)2018-07-06 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythema
00855360006083 - Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well)2018-07-06 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythema
00855360006113 - Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well)2018-07-06 INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythemat

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.