25OH Vitamin D Total

GUDID 05400569000230

25OH Vitamin D Total ELISA

Diasource Immunoassays S.A. SA

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

• Primary Device ID: 05400569000230
• NIH Device Record Key: 06771f9f-cf42-49b9-ad77-4938cff4f895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25OH Vitamin D Total
• Version Model Number: KAP1971
• Company DUNS: 458777323
• Company Name: Diasource Immunoassays S.A. SA
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05400569000230 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-10
• Device Publish Date: 2019-08-21

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