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DSQ Alert™ Parechovirus v2.0 Probe Mix ASR

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
DSQ Alert™ Parechovirus v2.0 Probe Mix ASR FDA UDI
Generic Name
Human parechovirus (HPeV) nucleic acid IVD, reagent FDA UDI
Device Name
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. FDA UDI
Model / Reference
M800759 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
M800759 FDA UDI
Primary DI / UDI-DI
03661540952708 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Human parechovirus (HPeV) nucleic acid IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Human parechovirus (HPeV) nucleic acid IVD, reagent

DSQ Alert™ Parechovirus v2.0 Probe Mix ASR by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human parechovirus (HPeV) nucleic acid IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ELITechGroup MDX LLC.

Sources (1)

  • FDA UDI 6f507667-f9ec-419e-89b8-d899535c7d1f 36 fields · synced May 30, 2026