FDA.reportPublic FDA data

Allereye® Tear Total IgE Test Kit

Primary DI
00864525000408
Brand
Allereye® Tear Total IgE Test Kit
Company
BLUEJAY DIAGNOSTICS, INC.
Model
01
Catalog number
380003G
Device description
Allereye® is a rapid immunoassay for the detection of total IgE in tears.
Published
2020-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864525000408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864525000408008645250004088645250004080864525000408

GMDN Terms#

Term, Definition table
TermDefinition
Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of immunoglobulin E (IgE) antibodies to multiple specific protein allergens and/or total immunoglobulin E (IgE total) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(844) 327-7078contact@bluejaydx.com

Regulatory Flags#

DUNS number
080412181
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864525000422Cambridge Biotech HIV-1 Urine Western Blot Kit01450002020-06-15
00864525000415Maxim HIV-1 Urine Enzyme Immunoassay01400002019-07-17