Audit MicroControls Linearity FLQ Thyroids for Roche Systems

GUDID B085K926M50

AALTO SCIENTIFIC

Multiple thyroid marker IVD, control
Primary Device IDB085K926M50
NIH Device Record Key19781e8f-e67a-48e3-9bac-4c3126249007
Commercial Distribution StatusIn Commercial Distribution
Brand NameAudit MicroControls Linearity FLQ Thyroids for Roche Systems
Version Model NumberK926M-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
HIBCCB085K926M50 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-04
Device Publish Date2019-07-23

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