25 OH Vitamin D Total (90') ELISA EIA-6087

GUDID 00840239060877

The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay

DRG International Inc

Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239060877
• NIH Device Record Key: 117edbab-405f-4fa3-83df-a8b370aaca26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25 OH Vitamin D Total (90') ELISA
• Version Model Number: EIA-6087
• Catalog Number: EIA-6087
• Company DUNS: 075150847
• Company Name: DRG International 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

Customer Support Contacts

• Phone: 1 973-564-7555
• Email: corpoffice@drg-international.com
• Phone: 1 973-564-7555
• Email: corpoffice@drg-international.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239060877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123364

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: 2023-09-04
• Device Publish Date: 2023-08-26