Access Intrinsic Factor Ab 387992

GUDID 15099590229146

The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human

Beckman Coulter, Inc.

Intrinsic factor antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15099590229146
• NIH Device Record Key: 915ee7ee-01f6-42e5-937e-1cb6c23a9821
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Intrinsic Factor Ab
• Version Model Number: 387992
• Catalog Number: 387992
• 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	15099590229146 [Primary]

FDA Product Code

• LIG: Radioassay, Intrinsic Factor Blocking Antibody

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-09
• Device Publish Date: 2016-09-09

Devices Manufactured by Beckman Coulter, Inc.

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• 05099590798218 - DxH: 2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid
• 14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590209636 - DxH: 2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and