ABBOTT MOLECULAR INC.

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

REAGENTS,SPECIFIC,ANALYTE (MVU) (8) ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS (MZP) (1) CLINICAL SAMPLE CONCENTRATOR (JJH) (1)

Premarket Exempt

No Yes

Clear

m2000 - 00884999000414 Catalog Number : 01N06-01

Device Description : Reagent Vessel Carrier Assembly

Device Class : 1

Duns Number: 878263359

Premarket Exempt : No

Product Code : JJH

Prescription Use : Yes

Device Count : 1

Vysis - 00884999000476 Catalog Number : 01N12-010

Device Description : Vysis LSI SNRPN SpectrumOrange/CEP 15 SpectrumAqua/PML SpectrumGreen

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999000483 Catalog Number : 01N13-010

Device Description : Vysis LSI D15S10 SO/CEP 15 SA/PML SGn Probes

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999000490 Catalog Number : 01N14-010

Device Description : Vysis LSI TUPLE1 SpectrumOrange/TelVysion 22q SpectrumGreen

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999000513 Catalog Number : 01N15-020

Device Description : Vysis LSI MDM2 SpectrumOrange Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999000520 Catalog Number : 01N17-020

Device Description : Vysis LSI TP53 SpectrumOrange/CEP 17 SpectrumGreen Probes

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999000537 Catalog Number : 01N18-020

Device Description : Vysis LSI ATM SpectrumOrange/CEP 11 SpectrumGreen Probes

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999000544 Catalog Number : 01N20-020

Device Description : Vysis LSI D13S319 SpectrumOrange/LSI 13q34 SpectrumGreen Probes

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999000582 Catalog Number : 01N23-020

Device Description : Vysis LSI BCL6 Dual Color Break Apart Rearrangement Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealTime - 00884999000698 Catalog Number : 1N30-66

Device Description : Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV (List Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV (List Number 1N30-90)

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : MZP

Prescription Use : Yes

Device Count : 1

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