Audit MicroControls Control LQ Spinal Fluid

GUDID B085K060M60

AALTO SCIENTIFIC

Multiple clinical chemistry analyte IVD, control
Primary Device IDB085K060M60
NIH Device Record Key95ff0900-6847-46c9-b26e-b564a1c5e59e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAudit MicroControls Control LQ Spinal Fluid
Version Model NumberK060M-6
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
HIBCCB085K060M60 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-27
Device Publish Date2018-03-27

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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
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B085K061M60 - Audit MicroControls Control FD HbA1c2025-02-03
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