ImmunoWELL Cardiolipin (IgG) Test 3090

GUDID 00613745030906

The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.

Genbio

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00613745030906
NIH Device Record Key4c17cfad-23c1-4d2d-9802-ba17497a4485
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoWELL Cardiolipin (IgG) Test
Version Model Number800-3090
Catalog Number3090
Company DUNS940425333
Company NameGenbio
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-592-9300
Emailsupport@genbio.com
Phone858-592-9300
Emailsupport@genbio.com
Phone858-592-9300
Emailsupport@genbio.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613745030906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIDSystem, Test, Anticardiolipin Immunological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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