NeuMoDx Molecular, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010729479	3010729479	NeuMoDx Molecular, Inc.	1	N	2020-04-25	1250 Eisenhower Place Ann Arbor MI US 48108

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
10814278020014	NeuMoDx™ 288 Molecular System - NeuMoDx™ 288 Molecular System	+1(734)372-2617	ewinnega@neumodx.com
10814278020045	NeuMoDxTM GBS Test Strip - NeuMoDx GBS Test Strip	+1(734)372-2617	ewinnega@neumodx.com
10814278020724	NeuMoDx™ 96 Molecular System - 500200	+1(734)372-2617	ewinnega@neumodx.com

neumodx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
211718	2032549847	K173725	NeuMoDx GBS Assay	NJR	2018-06-26
211718	1035210107
211718	1071417074
211718	1190788303
211718	1434987535
211718	1437662823
211718	1471158614
211718	1552339899
211718	1764714734
211718	1982031381

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NJR	1	2018-06-26

PMN#

NeuMoDx CT/NG Assay 2.0
2023-12-22
Neumodx Molecular, Inc.
NeuMoDx GBS Assay
2018-06-26
NeuMoDx Molecular, Inc.

GUDID#

NeuMoDx™ 288 Molecular System - NeuMoDx™ 288 Molecular System
Neumodx Molecular, Inc.
2019-03-29
NeuMoDx™ 96 Molecular System - 500200
Neumodx Molecular, Inc.
2019-03-29
NeuMoDx™ Lysis Buffer 5 - 400900
Neumodx Molecular, Inc.
2021-12-13
NeuMoDx™ Lysis Buffer 6 - 401700
Neumodx Molecular, Inc.
2020-03-19
NeuMoDx™ Viral Lysis Buffer - 401600
Neumodx Molecular, Inc.
2020-03-20
NeuMoDx SARS-CoV-2 Test Strip - 300800
Neumodx Molecular, Inc.
2020-04-23
NeuMoDx™ Vantage Viral Lysis Buffer - 401500
Neumodx Molecular, Inc.
2021-12-13
NeuMoDxTM GBS Test Strip - NeuMoDx GBS Test Strip
Neumodx Molecular, Inc.
2019-04-03
NeuMoDxTM LDT Master Mix, DNA - NeuMoDx LDT Master Mix, DNA
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM LDT Master Mix, RNA - NeuMoDx LDT Master Mix, RNA
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Wash Reagent - NeuMoDx Wash Reagent
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Release Reagent - NeuMoDx Release Reagent
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Lysis Buffer 1 - NeuMoDx Lysis Buffer 1
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Lysis Buffer 2 - NeuMoDx Lysis Buffer 2
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Lysis Buffer 3 - NeuMoDx Lysis Buffer 3
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Lysis Buffer 4 - NeuMoDx Lysis Buffer 4
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Cartridge - NeuMoDx Cartridge
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Extraction Plate - NeuMoDx Extraction Plate
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM LDT Probe/Primer Strip - NeuMoDx LDT Probe/Primer Strip
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM Biohazard Waste Bag - NeuMoDx Biohazard Waste Bag
Neumodx Molecular, Inc.
2019-03-29
NeuMoDx™ Lysis Buffer 5 - 400900
Neumodx Molecular, Inc.
2021-12-13
NeuMoDx™ Vantage Viral Lysis Buffer - 401500
Neumodx Molecular, Inc.
2021-12-13
NeuMoDx SARS-CoV-2 Test Strip - 300800
Neumodx Molecular, Inc.
2020-04-23
NeuMoDx™ Viral Lysis Buffer - 4001600
Neumodx Molecular, Inc.
2020-03-20
NeuMoDx™ Lysis Buffer 6 - 401700
Neumodx Molecular, Inc.
2020-03-19
NeuMoDxTM 96 Molecular System - NeuMoDx 96 Molecular System
Neumodx Molecular, Inc.
2019-03-29
NeuMoDxTM 288 Molecular System - NeuMoDx 288 Molecular System
Neumodx Molecular, Inc.
2019-03-29