Audit MicroControls Linearity FLQ Vitamin D for Roche Systems

GUDID B085K923M50

AALTO SCIENTIFIC

25-Hydroxy vitamin D3 IVD, control
Primary Device IDB085K923M50
NIH Device Record Key8e62d49f-cb99-46fa-a108-97ef83603616
Commercial Distribution StatusIn Commercial Distribution
Brand NameAudit MicroControls Linearity FLQ Vitamin D for Roche Systems
Version Model NumberK923M-5
Company DUNS077974989
Company NameAALTO SCIENTIFIC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB085K923M50 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-24
Device Publish Date2024-05-16

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