AALTO SCIENTIFIC

Address:230 Technology Pkwy,Eatonton,GA,31024,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2)

Premarket Exempt

Yes

Clear

Audit MicroControls Control LQ Homocysteine - B085K020M60 Catalog Number :

Device Class : 1

Duns Number: 077974989

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Audit MicroControls Control LQ hs-CRP - B085K021M60 Catalog Number :

Device Class : 1

Duns Number: 077974989

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Audit MicroControls Control FD BNP - B085K023M60 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Audit MicroControls Control FD Cardiac Markers - B085K026M60 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Audit MicroControls Control FD Assayed Chemistry, Level 1 - B085K0311100 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Audit MicroControls Control FD Assayed Chemistry, Level 2 - B085K0312100 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Audit MicroControls Control LQ Spinal Fluid - B085K060M60 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Audit MicroControls Control FD Glycohemoglobin A1c - B085K061M80 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Audit MicroControls Control LQ Ammonia/Ethanol - B085K062M60 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Audit MicroControls Control FD Immunoassay - B085K063M60 Catalog Number :

Device Class :

Duns Number: 077974989

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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