Cambridge Biotech HIV-1 Urine Western Blot Kit

Basic Information

• Brand Name: Cambridge Biotech HIV-1 Urine Western Blot Kit
• Primary DI: 00864525000422
• Version / Model: 01
• Catalog Number: 45000
• Company Name: BLUEJAY DIAGNOSTICS, INC.
• Labeler DUNS: 080412181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 27
• Record Status: Published
• Publish Date: 2020-06-15
• Public Version: 1
• Public Version Date: 2020-06-23
• Public Version Status: New
• Public Device Record Key: b0001861-1b6d-4921-96f2-beb233c73e36

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
48482	HIV1 antibody IVD, kit, immunoblot	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 immunoblot assay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864525000422	GS1
Unit of Use	00450000000027	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]