FDA UDI
In Commercial Distribution
🇺🇸 United States
DSQ Alert BK Virus v3.0 Primer Mix
DI: 03661540952746
·
Model: M800726
·
Elitechgroup Mdx LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DSQ Alert BK Virus v3.0 Primer Mix
- Primary DI
- 03661540952746
- Version / Model
- M800726
- Company Name
- Elitechgroup Mdx LLC
- Labeler DUNS
- 117458512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-15
- Public Version
- 1
- Public Version Date
- 2024-05-23
- Public Version Status
- New
- Public Device Record Key
- c3d6b64d-8f4b-40da-8f28-216de71a881b
Device Description
DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus. The mix consists of a total of 6.4 nmol of primers per vial in a 1X TE buffer solution. The primers target a 72 bp region of the major capsid protein VP1 gene of the BK Virus. The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
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 |
|---|---|---|---|---|
| 49849 | BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from BK virus (BKV) in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540952746 | GS1 |