Diasorin Inc.

Address:1951 Northwestern Ave,Stillwater,MN,55082,US

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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

Assayed Quality Control Material For Clinical Microbiology Assays (QCH) (1) Immunoassay For Host Biomarkers Of Infection (QPS) (1)

Premarket Exempt

No Yes

Clear

LIAISON MeMed BV - 08056771602969 Catalog Number :

Device Description : The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemilumine The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples.

Device Class : 2

Duns Number: 033429783

Premarket Exempt : No

Product Code : QPS

Prescription Use : Yes

Device Count : 1

LIAISON MeMed BV Control Set - 08056771602976 Catalog Number :

Device Description : The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay.

Device Class : 2

Duns Number: 033429783

Premarket Exempt : No

Product Code : QCH

Prescription Use : Yes

Device Count : 1

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