Cambridge Biotech HIV-1 Urine Western Blot Kit

Primary DI
00864525000422
Brand
Cambridge Biotech HIV-1 Urine Western Blot Kit
Company
BLUEJAY DIAGNOSTICS, INC.
Model
01
Catalog number
45000
Device description
The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine specimens. This more specific assay is used as a supplemental test with urine specimens that tested repeatedly reactive using a screening procedure (Urine EIA Kit). The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection.
Published
2020-06-15
Public version status
New
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
00864525000422PrimaryGS10
00450000000027Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864525000422008645250004228645250004220864525000422
00450000000027004500000000274500000000270450000000027

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 antibody IVD, kit, immunoblotA 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 immunoblot assay method.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080412181
Device count
27
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
00864525000415Maxim HIV-1 Urine Enzyme Immunoassay01400002019-07-17