APPLIED SPECTRAL IMAGING LTD.

Address:2 HaCarmel St.,Yokneam Northern,IL

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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

Analyzer, Chromosome, Automated (LNJ) (3) Device, Automated Cell-Locating (JOY) (3) Microscope, Automated, Image Analysis, Operator Intervention (NOT) (3) Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity (NQN) (3) System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays (NTH) (3)

Premarket Exempt

Clear

GenASIs™ System - 07290016630008 Catalog Number :

Device Class : 2

Duns Number: 600741763

Premarket Exempt : No

Product Code : NTH, LNJ, NQN, NOT, JOY

Prescription Use : No

Device Count : 1

GenASIs™ System - 07290016630015 Catalog Number :

Device Class : 2

Duns Number: 600741763

Premarket Exempt : No

Product Code : JOY, NOT, NQN, LNJ, NTH

Prescription Use : No

Device Count : 1

ASI IVD System - 07290016630039 Catalog Number :

Device Description : ASI IVD System with software version GenASIs V-8.3

Device Class : 2

Duns Number: 600741763

Premarket Exempt : No

Product Code : JOY, NOT, NQN, LNJ, NTH

Prescription Use : Yes

Device Count : 1

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