Neumodx Molecular

FDA Filings

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

FDA Registration(s)
Registration Number3010729479
FEI Number3010729479
NameNeuMoDx Molecular, Inc.
Owner & OperatorNeuMoDx Molecular
Contact Address1250 Eisenhower Place
Ann Arbor MI 48108 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1250 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
DeviceDate
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? SARS-CoV-2 Test Strip2020-03-24
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? SARS-CoV-2 Assay2020-03-24
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx TV/MG Test Strip2019-12-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx TV/MG Assay2019-12-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx CT/NG Test Strip2019-12-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx CT/NG Assay2019-12-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Strep A/C/G Vantage Test Strip2019-12-04
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Strep A/C/G Vantage Assay2019-12-04
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? CMV Quant Assay2019-12-04
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? HCV Quant Assay2019-12-04
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? HBV Quant Assay2019-12-04
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? EBV Quant Assay2019-12-04
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? GBS Test Strip2018-07-26
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? 288 Molecular System2018-07-26
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? GBS Test Strip2018-07-26
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? 288 Molecular System2018-07-26
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Wash Reagent2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Viral Lysis Buffer2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Release Reagent2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Lysis Buffer 62017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Lysis Buffer 52017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Lysis Buffer 42017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Lysis Buffer 32017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Lysis Buffer 22017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Lysis Buffer 12017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? LDT Test Strip2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? LDT Master Mix, RNA2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? LDT Master Mix, DNA2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Extraction Plate2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? Cartridge2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
Biohazardous Waste Bag2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? 96 Molecular System2017-10-16
NeuMoDx Molecular, Inc. [NeuMoDx Molecular]
NeuMoDx? 288 Molecular System2017-10-16

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