AccessGUDID - DEVICE: DSQ Alert™ Parechovirus v2.0 Probe Mix ASR (03661540952708)

GUDID

Device Identifier (DI) Information

Brand Name: DSQ Alert™ Parechovirus v2.0 Probe Mix ASR
Version or Model: M800759
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M800759
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540952708
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the AP593 fluorophore and has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm.

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:	No
Prescription Use (Rx):	No
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?
50002	Human parechovirus (HPeV) nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from one or multiple strains of Human parechovirus (HPeV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

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 Temperature: less than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f507667-f9ec-419e-89b8-d899535c7d1f
Public Version Date: November 14, 2023
Public Version Number: 2
DI Record Publish Date: October 05, 2023