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 ID08809317540337
NIH Device Record Key2cd1bbce-f7b7-4e9d-9c22-cf6192fe423d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREND Vitamin D
Version Model NumberFRVD-AP
Catalog NumberFRVDAP 020
Company DUNS687910463
Company NameNanoEnTek, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809317540337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRGSystem, Test, Vitamin D

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-22
Device Publish Date2017-01-27

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