NeuMoDxTM 288 Molecular System 500100

GUDID 00814278020727

NeuMoDx 288 Molecular System

Neumodx Molecular, Inc.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated
Primary Device ID00814278020727
NIH Device Record Key8e0d588d-0c48-4bd8-853b-d596c23aa207
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuMoDxTM 288 Molecular System
Version Model Number500100
Catalog Number500100
Company DUNS078667309
Company NameNeumodx Molecular, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com
Phone+1(734)372-2617
Emailewinnega@neumodx.com

Device Dimensions

Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter
Depth109.2 Centimeter
Width182.9 Centimeter
Height190.5 Centimeter

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814278020727 [Direct Marking]
GS110814278020014 [Primary]
GS110814278020724 [Primary]

FDA Product Code

OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-08
Device Publish Date2019-03-29

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