Primary Device ID | 00855360006250 |
NIH Device Record Key | a24600ff-0699-4375-857c-0707882ccc3e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | REAADS Coagulation Control 2 |
Version Model Number | 702-001 |
Catalog Number | 702-001 |
Company DUNS | 619834542 |
Company Name | CORGENIX MEDICAL CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-729-5661 |
technicalsupport@corgenix.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00855360006250 [Primary] |
GGC | Control, Plasma, Abnormal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-07-14 |
00855360006007 - REAADS Protein S Antigen Test kit | 2018-07-06 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 Antigen | 2018-07-06 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrat |
00855360006021 - REAADS Protein C Test Kit | 2018-07-06 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 Kit | 2018-07-06 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 |