Maxim HIV-1 Urine Enzyme Immunoassay

Primary DI
00864525000415
Brand
Maxim HIV-1 Urine Enzyme Immunoassay
Company
BLUEJAY DIAGNOSTICS, INC.
Model
01
Catalog number
40000
Device description
The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine. The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection. Before a determination of HIV-1 status can be made, specimens that are repeatedly reactive using this test should be further tested only using the additional, more specific, Cambridge Biotech HIV-1 Urine Western Blot test.
Published
2019-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864525000415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864525000415008645250004158645250004150864525000415

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the human immunodeficiency virus 1 (HIV1) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
00864525000408Allereye® Tear Total IgE Test Kit01380003G2020-06-15
00864525000422Cambridge Biotech HIV-1 Urine Western Blot Kit01450002020-06-15