ACCESS HIV Ag/Ab combo Calibrators C39451

GUDID 15099590745165

The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in human serum and plasma, using the DxI 9000 Access Immunoassay Analyzer.

Beckman Coulter, Inc.

HIV1/HIV2 antigen/antibody IVD, calibrator

• Primary Device ID: 15099590745165
• NIH Device Record Key: 7ad74d73-3d46-455d-b753-fcf62293b6ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCESS HIV Ag/Ab combo Calibrators
• Version Model Number: C39451
• Catalog Number: C39451
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590745165 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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: 2024-03-25
• Device Publish Date: 2024-03-15

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