Identity
- Trade Name
- DSQ Alert™ Parechovirus v2.0 Primer Mix ASR FDA UDI
- Generic Name
- Human parechovirus (HPeV) nucleic acid IVD, reagent FDA UDI
- Device Name
- DSQ Alert Parechovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 130 bp region of the 5’-UTR of parechovirus. FDA UDI
- Model / Reference
- M800758 FDA UDI
- Description
- DSQ Alert Parechovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 130 bp region of the 5’-UTR of parechovirus. FDA UDI
Identifiers
- Catalog Number
- M800758 FDA UDI
- Primary DI / UDI-DI
- 03661540952692 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 Primer 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI beb5394b-ff03-4791-8d30-322f01790885 36 fields · synced May 30, 2026