Neumodx Molecular Inc

FDA Filings

This page includes the latest FDA filings for Neumodx Molecular Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010729479
• FEI Number: 3010729479
• Name: NeuMoDx Molecular, Inc.
• Owner & Operator: NeuMoDx Molecular
• Contact Address: 1250 Eisenhower Place ; Ann Arbor MI 48108 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1250 Eisenhower Place ; Ann Arbor, MI 48108 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00814278021304 Neumodx Molecular, Inc.	NeuMoDx™ Vantage Viral Lysis Buffer 401500	2021-12-22
GUDID 00814278020864 Neumodx Molecular, Inc.	NeuMoDx™ Lysis Buffer 5 400900	2021-12-22
GUDID 00814278021267 Neumodx Molecular, Inc.	NeuMoDx SARS-CoV-2 Test Strip 300800	2020-05-01
GUDID 00814278021250 Neumodx Molecular, Inc.	NeuMoDx™ Viral Lysis Buffer 401600	2020-03-30
GUDID 00814278021212 Neumodx Molecular, Inc.	NeuMoDx™ Lysis Buffer 6 401700	2020-03-27
QJR NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? SARS-CoV-2 Test Strip	2020-03-24
QJR NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? SARS-CoV-2 Assay	2020-03-24
QEP NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx TV/MG Test Strip	2019-12-16
QEP NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx TV/MG Assay	2019-12-16
QEP NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx CT/NG Test Strip	2019-12-16
QEP NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx CT/NG Assay	2019-12-16
PGX NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Strep A/C/G Vantage Test Strip	2019-12-04
PGX NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Strep A/C/G Vantage Assay	2019-12-04
PAB NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? CMV Quant Assay	2019-12-04
MZP NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? HCV Quant Assay	2019-12-04
MKT NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? HBV Quant Assay	2019-12-04
LSF NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? EBV Quant Assay	2019-12-04
GUDID 10814278020045 Neumodx Molecular, Inc.	NeuMoDxTM GBS Test Strip 200400	2019-04-11
GUDID 10814278020663 Neumodx Molecular, Inc.	NeuMoDxTM Biohazard Waste Bag 600100	2019-04-08
GUDID 10814278020304 Neumodx Molecular, Inc.	NeuMoDxTM LDT Probe/Primer Strip 100400	2019-04-08
GUDID 10814278020281 Neumodx Molecular, Inc.	NeuMoDxTM Extraction Plate 100200	2019-04-08
GUDID 10814278020274 Neumodx Molecular, Inc.	NeuMoDxTM Cartridge 100100	2019-04-08
GUDID 10814278020267 Neumodx Molecular, Inc.	NeuMoDxTM Lysis Buffer 4 400700	2019-04-08
GUDID 10814278020250 Neumodx Molecular, Inc.	NeuMoDxTM Lysis Buffer 3 400600	2019-04-08
GUDID 10814278020243 Neumodx Molecular, Inc.	NeuMoDxTM Lysis Buffer 2 400500	2019-04-08
GUDID 10814278020236 Neumodx Molecular, Inc.	NeuMoDxTM Lysis Buffer 1 400400	2019-04-08
GUDID 10814278020229 Neumodx Molecular, Inc.	NeuMoDxTM Release Reagent 400200	2019-04-08
GUDID 10814278020212 Neumodx Molecular, Inc.	NeuMoDxTM Wash Reagent 400100	2019-04-08
GUDID 10814278020205 Neumodx Molecular, Inc.	NeuMoDxTM LDT Master Mix, RNA 310100	2019-04-08
GUDID 10814278020199 Neumodx Molecular, Inc.	NeuMoDxTM LDT Master Mix, DNA 210100	2019-04-08
GUDID 00814278020727 Neumodx Molecular, Inc.	NeuMoDxTM 288 Molecular System 500100	2019-04-08
GUDID 00814278020000 Neumodx Molecular, Inc.	NeuMoDxTM 96 Molecular System 500200	2019-04-08
PMN K173725 | OOI NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? GBS Test Strip	2018-07-26
PMN K173725 | OOI NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? 288 Molecular System	2018-07-26
PMN K173725 | NJR NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? GBS Test Strip	2018-07-26
PMN K173725 | NJR NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? 288 Molecular System	2018-07-26
PMN K173725 NeuMoDx Molecular, Inc.	NeuMoDx GBS Assay	2018-06-26
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Wash Reagent	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Viral Lysis Buffer	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Release Reagent	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Lysis Buffer 6	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Lysis Buffer 5	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Lysis Buffer 4	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Lysis Buffer 3	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Lysis Buffer 2	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Lysis Buffer 1	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? LDT Test Strip	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? LDT Master Mix, RNA	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? LDT Master Mix, DNA	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Extraction Plate	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? Cartridge	2017-10-16
PPM NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	Biohazardous Waste Bag	2017-10-16
OOI NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? 96 Molecular System	2017-10-16
OOI NeuMoDx Molecular, Inc. [NeuMoDx Molecular]	NeuMoDx? 288 Molecular System	2017-10-16

Related Finance Registrations

SEC

0001546171

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