Neumodx Molecular, Inc.

Address:1250 Eisenhower Place,Ann Arbor,MI,48108,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) (4) General purpose reagent (PPM) (4) Reagents, 2019-Novel Coronavirus Nucleic Acid (QJR) (1) real time Nucleic acid amplification system (OOI) (1)

Premarket Exempt

No Yes

Clear

NeuMoDxTM Cartridge - 10814278020274 Catalog Number : 100100

Device Description : NeuMoDx Cartridge

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 48

NeuMoDxTM Extraction Plate - 10814278020281 Catalog Number : 100200

Device Description : NeuMoDx Extraction Plate

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 16

NeuMoDxTM LDT Probe/Primer Strip - 10814278020304 Catalog Number : 100400

Device Description : NeuMoDx LDT Probe/Primer Strip

Device Class :

Duns Number: 078667309

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 6

NeuMoDxTM Biohazard Waste Bag - 10814278020663 Catalog Number : 600100

Device Description : NeuMoDx Biohazard Waste Bag

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 5

NeuMoDx™ 96 Molecular System - 10814278020724 Catalog Number : 500200

Device Description : NeuMoDx™ 96 Molecular System

Device Class : 2

Duns Number: 078667309

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

NeuMoDx™ Lysis Buffer 5 - 10814278020861 Catalog Number : 400900

Device Description : NeuMoDx™ Lysis Buffer 5

Device Class : 1

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 4

NeuMoDx™ Lysis Buffer 6 - 10814278021219 Catalog Number : 401700

Device Description : NeuMoDx™ Lysis Buffer 6

Device Class : 1

Duns Number: 078667309

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 4

NeuMoDx™ Viral Lysis Buffer - 10814278021257 Catalog Number : 401600

Device Description : NeuMoDx™ Viral Lysis Buffer

Device Class : 1

Duns Number: 078667309

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 2

NeuMoDx SARS-CoV-2 Test Strip - 10814278021264 Catalog Number : 300800

Device Class :

Duns Number: 078667309

Premarket Exempt : Yes

Product Code : QJR

Prescription Use : Yes

Device Count : 6

NeuMoDx™ Vantage Viral Lysis Buffer - 10814278021301 Catalog Number : 401500

Device Description : NeuMoDx™ Vantage Viral Lysis Buffer

Device Class : 1

Duns Number: 078667309

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 2

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