Maxim HIV-1 Urine Enzyme Immunoassay 40000

GUDID 00864525000415

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.

BLUEJAY DIAGNOSTICS, INC.

HIV1 antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00864525000415
• NIH Device Record Key: f9684808-a945-4bb0-8488-2519ad6bd0d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxim HIV-1 Urine Enzyme Immunoassay
• Version Model Number: 01
• Catalog Number: 40000
• Company DUNS: 080412181
• Company Name: BLUEJAY DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (844) 327-7078
• Email: contact@bluejaydx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864525000415 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-25
• Device Publish Date: 2019-07-17

Devices Manufactured by BLUEJAY DIAGNOSTICS, INC.

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• 00864525000422 - Cambridge Biotech HIV-1 Urine Western Blot Kit: 2020-06-23 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 Immunoassay: 2019-07-25The 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.
• 00864525000415 - Maxim HIV-1 Urine Enzyme Immunoassay: 2019-07-25 The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodefici