ABBOTT MOLECULAR INC.

Address:1300 EAST TOUHY AVENUE,Des Plaines,IL,60018,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

General purpose reagent (PPM) (5) Dna-probe kit, human chromosome (OYU) (2) STAINER, TISSUE, AUTOMATED (KEY) (1) System, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays (NTH) (1) Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence (NSD) (1)

Premarket Exempt

No Yes

Clear

Vysis - 00884999001848 Catalog Number : 02J05-010

Device Description : ProbeChek PATHVISION HER-2/neu Normal Control Slides

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : NTH

Prescription Use : Yes

Device Count : 1

PathVysion - 00884999001855 Catalog Number : 02J05-030

Device Description : ProbeChek PathVysion HER-2/neu Normal Control Slides

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : OYU

Prescription Use : No

Device Count : 1

VP2000 - 00884999001862 Catalog Number : 02J06-030

Device Description : VP 2000 Pretreatment Reagent 500 for Laboratory Use

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

VP2000 - 00884999001879 Catalog Number : 02J07-030

Device Description : VP 2000 Protease Buffer (0.01 N HCl) 500 mL For Laboratory Use

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Vysis - 00884999001886 Catalog Number : 02J08-032

Device Description : Vysis LSI Protease 1, 2 x 250 mg

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

VP2000 - 00884999001893 Catalog Number : 02J09-030

Device Description : Vysis VP 2000 Magnesium Chloride 100X For Laboratory Use

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Vysis - 00884999001909 Catalog Number : 02J10-032

Device Description : 20X SSC, 500g For Laboratory Use

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

VP2000 - 00884999001916 Catalog Number : 02J11-001

Device Description : VP2000 Processor

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : KEY

Prescription Use : No

Device Count : 1

UroVysion - 00884999002128 Catalog Number : 02J27-011

Device Description : ProbeChek UroVysion Bladder Cancer Kit Control Slides

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : OYU

Prescription Use : Yes

Device Count : 1

UroVysion - 00884999002142 Catalog Number : 02J27-025

Device Description : UroVysion Bladder Cancer Kit

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : NSD

Prescription Use : Yes

Device Count : 1

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