FREND Vitamin D FRVDAP 020

GUDID 08809317540337

It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma.

NanoEnTek, Inc.

Multiple form 25-hydroxy Vitamin D IVD, reagent

• Primary Device ID: 08809317540337
• NIH Device Record Key: 2cd1bbce-f7b7-4e9d-9c22-cf6192fe423d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREND Vitamin D
• Version Model Number: FRVD-AP
• Catalog Number: FRVDAP 020
• Company DUNS: 687910463
• Company Name: NanoEnTek, 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: false
• 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	08809317540337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162754

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: 4
• Public Version Date: 2024-07-22
• Device Publish Date: 2017-01-27

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• 08809317540337 - FREND Vitamin D: 2024-07-22 It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plas