Neumodx Molecular, Inc.

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) (8) Nucleic acid amplification assay system, group b streptococcus, direct specimen test (NJR) (1) real time Nucleic acid amplification system (OOI) (1)

Premarket Exempt

No Yes

Clear

NeuMoDx™ 288 Molecular System - 10814278020014 Catalog Number : 500100

Device Description : NeuMoDx™ 288 Molecular System

Device Class : 2

Duns Number: 078667309

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

NeuMoDxTM GBS Test Strip - 10814278020045 Catalog Number : 200400

Device Description : NeuMoDx GBS Test Strip

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 6

NeuMoDxTM LDT Master Mix, DNA - 10814278020199 Catalog Number : 210100

Device Description : NeuMoDx LDT Master Mix, DNA

Device Class :

Duns Number: 078667309

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 6

NeuMoDxTM LDT Master Mix, RNA - 10814278020205 Catalog Number : 310100

Device Description : NeuMoDx LDT Master Mix, RNA

Device Class :

Duns Number: 078667309

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 6

NeuMoDxTM Wash Reagent - 10814278020212 Catalog Number : 400100

Device Description : NeuMoDx Wash Reagent

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 2

NeuMoDxTM Release Reagent - 10814278020229 Catalog Number : 400200

Device Description : NeuMoDx Release Reagent

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 2

NeuMoDxTM Lysis Buffer 1 - 10814278020236 Catalog Number : 400400

Device Description : NeuMoDx Lysis Buffer 1

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 4

NeuMoDxTM Lysis Buffer 2 - 10814278020243 Catalog Number : 400500

Device Description : NeuMoDx Lysis Buffer 2

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 4

NeuMoDxTM Lysis Buffer 3 - 10814278020250 Catalog Number : 400600

Device Description : NeuMoDx Lysis Buffer 3

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 4

NeuMoDxTM Lysis Buffer 4 - 10814278020267 Catalog Number : 400700

Device Description : NeuMoDx Lysis Buffer 4

Device Class :

Duns Number: 078667309

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 4

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