Access Vitamin B12 33000

GUDID H628330001

Beckman Coulter, Inc.

Vitamin B12 IVD kit, chemiluminescent immunoassay

• Primary Device ID: H628330001
• NIH Device Record Key: 63705226-9f33-49a6-afd7-5f2f9595563c
• 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: true
• 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
HIBCC	H628330001 [Primary]

FDA Product Code

• CDD: Radioassay, Vitamin B12

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: 2015-10-31

On-Brand Devices [Access Vitamin B12]

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