FDA.reportPublic FDA data

NeuMoDx™ 96 Molecular System

Primary DI
10814278020724
Brand
NeuMoDx™ 96 Molecular System
Company
Neumodx Molecular, Inc.
Model
500200
Catalog number
500200
Device description
NeuMoDx™ 96 Molecular System
Published
2019-03-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814278020000Direct MarkingGS10
10814278020724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814278020000008142780200008142780200000814278020000
1081427802072410814278020724

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth109.2Centimeter
Height109.2Centimeter
Width137.2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius28 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(734)372-2617ewinnega@neumodx.com

Regulatory Flags#

DUNS number
078667309
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814278020014NeuMoDx™ 288 Molecular System5001005001002019-03-29
10814278020861NeuMoDx™ Lysis Buffer 54009004009002021-12-13
10814278021219NeuMoDx™ Lysis Buffer 64017004017002020-03-19
10814278021257NeuMoDx™ Viral Lysis Buffer4016004016002020-03-20
10814278021264NeuMoDx SARS-CoV-2 Test Strip3008003008002020-04-23
10814278021301NeuMoDx™ Vantage Viral Lysis Buffer4015004015002021-12-13
10814278020045NeuMoDxTM GBS Test Strip2004002004002019-04-03
10814278020199NeuMoDxTM LDT Master Mix, DNA2101002101002019-03-29
10814278020205NeuMoDxTM LDT Master Mix, RNA3101003101002019-03-29
10814278020212NeuMoDxTM Wash Reagent4001004001002019-03-29
10814278020229NeuMoDxTM Release Reagent4002004002002019-03-29
10814278020236NeuMoDxTM Lysis Buffer 14004004004002019-03-29
10814278020243NeuMoDxTM Lysis Buffer 24005004005002019-03-29
10814278020250NeuMoDxTM Lysis Buffer 34006004006002019-03-29
10814278020267NeuMoDxTM Lysis Buffer 44007004007002019-03-29
10814278020274NeuMoDxTM Cartridge1001001001002019-03-29
10814278020281NeuMoDxTM Extraction Plate1002001002002019-03-29
10814278020304NeuMoDxTM LDT Probe/Primer Strip1004001004002019-03-29
10814278020663NeuMoDxTM Biohazard Waste Bag6001006001002019-03-29
00814278020864NeuMoDx™ Lysis Buffer 54009004009002021-12-13

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