Leica Biosystems Richmond, Inc.

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

MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY (NQN) (6) DEVICE, AUTOMATED CELL-LOCATING (JOY) (4)

Premarket Exempt

No Yes

Clear

Leica Biosystems CytoVision GSL WinXP->Win7 with current CV version - 00849832003762 Catalog Number :

Device Description : Leica Biosystems CytoVision GSL WinXP->Win7 with current CV version

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision Brightfield & FL ChromaScan upgrade - 00849832003779 Catalog Number :

Device Description : Leca Biosystems CytoVision Brightfield & FL ChromaScan upgrade

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision Brightfield ChromaScan upgrade - 00849832003786 Catalog Number :

Device Description : Leica Biosystems CytoVision Brightfield ChromaScan upgrade

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems CytoVision Karyotyping Software Update - 00849832003793 Catalog Number :

Device Description : Leica Biosystems CytoVision Karyotyping Software Update

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

Leica Biosystems Ariol DM6000B Workstation - 00849832003809 Catalog Number :

Device Description : Leica Biosystems Ariol DM6000B Workstation

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

Leica Ariol SL200 Basw Workstation - 00849832003816 Catalog Number :

Device Description : Leica Ariol SL200 Base Workstation

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

Leica Biosystems Ariol Review Station - 00849832003823 Catalog Number :

Device Description : Leica Biosystems Ariol Review Station

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

Leica Biosystems Ariol Review Software - 00849832003830 Catalog Number :

Device Description : Leica Biosystems Ariol Review Software

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

Leica Biosystems Ariol Fluorescent Module - 00849832003847 Catalog Number :

Device Description : Leica Biosystems Ariol Fluorescent Module

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

Leica Biosystems Ariol IHC Module - 00849832003854 Catalog Number :

Device Description : Leica Biosystems Ariol IHC Module

Device Class : 2

Duns Number: 082930884

Premarket Exempt : No

Product Code : NQN

Prescription Use : Yes

Device Count : 1

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