Linearity FLQ TDM for Beckman AU

GUDID B085K827M50

AALTO SCIENTIFIC

Multiple therapeutic drugs/drugs of abuse IVD, control
Primary Device IDB085K827M50
NIH Device Record Key30ed04f5-11b5-48cc-9aca-b3768b9f3173
Commercial Distribution StatusIn Commercial Distribution
Brand NameLinearity FLQ TDM for Beckman AU
Version Model NumberK827M-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
HIBCCB085K827M50 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-01
Device Publish Date2021-06-23

Devices Manufactured by AALTO SCIENTIFIC

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B085K865M50 - Audit MicroControls Linearity FD General Chemistry Panel 2 for Alfa Wassermann2025-03-14
B085K866M50 - Audit MicroControls Linearity FD General Chemistry Panel 3 for Alfa Wassermann2025-03-14
B085K867M100 - Audit MicroControls Linearity FD General Chemistry Panel 4 for Alfa Wassermann2025-03-14
B085K061M60 - Audit MicroControls Control FD HbA1c2025-02-03
B085K852M200 - Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1)2025-01-14

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