MEMED DIAGNOSTICS LTD

Address:5 Nahum Heth Street,Tirat Carmel Haifa,IL

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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

Immunoassay For Host Biomarkers Of Infection (QPS) (4) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1)

Premarket Exempt

No Yes

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MeMed Key® - 17290018739003 Catalog Number :

Device Class : 2

Duns Number: 533243445

Premarket Exempt : No

Product Code : QPS

Prescription Use : No

Device Count : 1

MeMed BV® - 17290018739010 Catalog Number :

Device Class :

Duns Number: 533243445

Premarket Exempt : No

Product Code : QPS

Prescription Use : No

Device Count : 12

MeMed BV® Calibrator - 17290018739027 Catalog Number :

Device Class : 2

Duns Number: 533243445

Premarket Exempt : No

Product Code : QPS

Prescription Use : No

Device Count : 1

MeMed BV® External Control - 17290018739034 Catalog Number :

Device Class : 2

Duns Number: 533243445

Premarket Exempt : No

Product Code : QPS

Prescription Use : No

Device Count : 1

Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP - 17290018739072 Catalog Number :

Device Description : The Performance Verification Kit contains a set of serum-based quantitative samp The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only.

Device Class : 1

Duns Number: 533243445

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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