Access Vitamin B12 33000

GUDID 15099590224301

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Vitamin B12 IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590224301
• NIH Device Record Key: 0973d6b7-8a6d-46f3-9478-9babdd2f36d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Vitamin B12
• Version Model Number: 33000
• Catalog Number: 33000
• 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	15099590224301 [Primary]

FDA Product Code

• CDD: Radioassay, Vitamin B12

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: 2025-09-17
• Device Publish Date: 2025-09-09

On-Brand Devices [Access Vitamin B12]

• H628330001: 33000
• 15099590224301: The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the qu