FDA UDI
In Commercial Distribution
🇺🇸 United States
DSQ Alert™ Parechovirus v2.0 Primer Mix ASR
DI: 03661540952692
·
Model: M800758
·
Elitechgroup Mdx LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DSQ Alert™ Parechovirus v2.0 Primer Mix ASR
- Primary DI
- 03661540952692
- Version / Model
- M800758
- Catalog Number
- M800758
- Company Name
- Elitechgroup Mdx LLC
- Labeler DUNS
- 117458512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-05
- Public Version
- 2
- Public Version Date
- 2023-11-14
- Public Version Status
- Update
- Public Device Record Key
- beb5394b-ff03-4791-8d30-322f01790885
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540952692 | GS1 |
Customer Contacts
- Phone
- 8004532725
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -10 Degrees Celsius