Access 25(OH) Vitamin D Total C28646

GUDID 15099590744397

The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the DxI Access Immunoassay Analyzers. Results are to be used as an aid in the assessment of vitamin D sufficiency.

Beckman Coulter, Inc.

25-Hydroxy vitamin D2 IVD, reagent

• Primary Device ID: 15099590744397
• NIH Device Record Key: 151b2685-ca90-4e55-9a5b-81b3d92886c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access 25(OH) Vitamin D Total
• Version Model Number: C28646
• Catalog Number: C28646
• 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	15099590744397 [Primary]

FDA Product Code

• MRG: System, Test, Vitamin D

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: 2023-02-13
• Device Publish Date: 2023-02-03

On-Brand Devices [Access 25(OH) Vitamin D Total]

• 15099590226558: The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay
• 15099590225964: The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay
• 15099590744397: The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay