LIAISON 25 OH Vitamin D Total Assay 200 test

GUDID 18056771602775

Diasorin Inc.

Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Primary Device ID18056771602775
NIH Device Record Key64d8d1dd-ffd5-462a-892b-a58533389d3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIAISON 25 OH Vitamin D Total Assay 200 test
Version Model Number318360
Company DUNS033429783
Company NameDiasorin 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 Usefalse
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
GS108056771602778 [Primary]
GS118056771602775 [Package]
Contains: 08056771602778
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-21
Device Publish Date2021-04-13

Devices Manufactured by Diasorin Inc.

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