Leica Biosystems Richmond, Inc.

Address:5205 Us Highway 12,Richmond,IL,60071,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

DEVICE, AUTOMATED CELL-LOCATING (JOY) (8) MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY (NQN) (2)

Premarket Exempt

No Yes

Clear

Leica Biosystems Ariol Rare Event Module - 00849832003861 Catalog Number :

Device Description : Leica Biosystems Ariol Rare Event Module

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

Leica Biosystems Ariol Workstation PC for Legacy Harware - 00849832003878 Catalog Number :

Device Description : Leica Biosystems Ariol Workstation PC for Legacy Hardware

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision GSL10 scanning system for FISH - 00849832003915 Catalog Number :

Device Description : Leica Biosystems CytoVision GSL10 scanning system for FISH

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision GSL120 scanning system - FISH - 00849832003922 Catalog Number :

Device Description : Leica Biosystems CytoVision GSL120 scanning system - FISH

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision MB8 scanning system for FISH - 00849832003939 Catalog Number :

Device Description : Leica Biosystems CytoVision MB8 scanning system for FISH

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision FISH Station w/ Jai MV4 Camera - 00849832003953 Catalog Number :

Device Description : Leica Biosystems CytoVision FISH Station w/Jai MV4 Camera

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision Auto Fish Capture System - 00849832004004 Catalog Number :

Device Description : Leica Biosystems CytoVision Auto Fish Capture System

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision DM2500 for FISH - 00849832004011 Catalog Number :

Device Description : Leica Biosystems CytoVision DM2500 for FISH

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision DM5500B for FISH - 00849832004059 Catalog Number :

Device Description : Leica Biosystems CytoVision DM5500B for FISH

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision DM5500 for FL-Ergo Head - 00849832004066 Catalog Number :

Device Description : Leica Biosystems CytoVision DM5500 for FL-Ergo Head

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

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