LUMINEX CORPORATION

Address:1224 Deming Way,Madison,WI,53717,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

Instrumentation for clinical multiplex test systems (NSU) (3) real time Nucleic acid amplification system (OOI) (2) Internal polymerase chain reaction control, not assay specific (OLD) (1) C.Difficile toxin gene amplification assay (OZN) (1) REAGENTS,SPECIFIC,ANALYTE (MVU) (1) Respiratory virus panel nucleic acid assay system (OCC) (1) Nucleic acid amplification assay system, group b streptococcus, direct specimen test (NJR) (1) Influenza A and influenza B multiplex nucleic acid assay (OZE) (1)

Premarket Exempt

No Yes

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ARIES® C. difficile Assay - 00840487100059 Catalog Number :

Device Description : The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) bas The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI).

Device Class : 2

Duns Number: 965476641

Premarket Exempt : No

Product Code : OZN

Prescription Use : Yes

Device Count : 1

ARIES® Extraction Kit - 00840487100073 Catalog Number :

Device Description : The ARIES® Extraction Kit is intended to extract nucleic acid from human biologi The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM).

Device Class : 2

Duns Number: 965476641

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

ARIES® M1 System - 00840487100080 Catalog Number :

Device Description : The ARIES® M1 System is a clinical multiplex test system that automates and inte The ARIES® M1 System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay.

Device Class : 2

Duns Number: 965476641

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

xMAP® Sheath Fluid - 00840487100097 Catalog Number :

Device Description : Sheath fluid is the delivery medium of the sample to the optics component.

Device Class : 2

Duns Number: 965476641

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

xMAP® Sheath Concentrate Pack - 00840487100103 Catalog Number :

Device Description : A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery me A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery medium of the sample to the optics component.

Device Class : 2

Duns Number: 965476641

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

Luminex® 100/200™ - 00840487100110 Catalog Number :

Device Description : The Luminex 100/200 System is a compact analyzer that performs up to 100 bioassa The Luminex 100/200 System is a compact analyzer that performs up to 100 bioassays simultaneously, using a single drop of fluid therefore requiring very small patient samples.

Device Class : 2

Duns Number: 965476641

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

MHV Control Primers 5 - 00840487100127 Catalog Number : 3806

Device Description : Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Device Class : 1

Duns Number: 079686463

Premarket Exempt : Yes

Product Code : OLD

Prescription Use : No

Device Count : 1

ARIES® Flu A/B & RSV Assay - 00840487100158 Catalog Number :

Device Description : The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualit The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

Device Class : 2

Duns Number: 965476641

Premarket Exempt : No

Product Code : OZE, OCC

Prescription Use : Yes

Device Count : 1

ARIES® GBS Assay - 00840487100165 Catalog Number :

Device Description : The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualit The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.

Device Class : 1

Duns Number: 965476641

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

MultiCode® Bordetella holmseii Primers - 00840487100196 Catalog Number : 3921

Device Description : Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens

Device Class : 1

Duns Number: 079686463

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

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