AccessGUDID - DEVICE: NeuMoDxTM LDT Master Mix, DNA (10814278020199)

GUDID

Device Identifier (DI) Information

Brand Name: NeuMoDxTM LDT Master Mix, DNA
Version or Model: 210100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210100
Company Name: Neumodx Molecular, Inc.

Primary DI Number: 10814278020199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 078667309 *Terms of Use

Device Description: NeuMoDx LDT Master Mix, DNA

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62623	Nucleic acid amplification mastermix reagent IVD	A reagent intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General purpose reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 20 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 28 Degrees Celsius
Handling Environment Humidity: between 20 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 18 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 97961cfe-18cc-4444-ab60-8b65bf1755d0
Public Version Date: April 08, 2019
Public Version Number: 1
DI Record Publish Date: March 29, 2019