Allereye® Tear Total IgE Test Kit 380003G

GUDID 00864525000408

Allereye® is a rapid immunoassay for the detection of total IgE in tears.

BLUEJAY DIAGNOSTICS, INC.

Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00864525000408
NIH Device Record Key5627acca-3b23-428a-aa60-5c573c822fd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllereye® Tear Total IgE Test Kit
Version Model Number01
Catalog Number380003G
Company DUNS080412181
Company NameBLUEJAY DIAGNOSTICS, INC.
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

Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]
GS100864525000408 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by BLUEJAY DIAGNOSTICS, INC.

00864525000408 - Allereye® Tear Total IgE Test Kit2020-06-23Allereye® is a rapid immunoassay for the detection of total IgE in tears.
00864525000408 - Allereye® Tear Total IgE Test Kit2020-06-23 Allereye® is a rapid immunoassay for the detection of total IgE in tears.
00864525000422 - Cambridge Biotech HIV-1 Urine Western Blot Kit2020-06-23 The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of anti
00864525000415 - Maxim HIV-1 Urine Enzyme Immunoassay2019-07-25 The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodefici

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.