FDA UDI
In Commercial Distribution
🇺🇸 United States
MGB Alert® BKV ASR v3.0 Probe Mix
DI: 03661540952357
·
Model: M800727
·
Elitechgroup Mdx LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MGB Alert® BKV ASR v3.0 Probe Mix
- Primary DI
- 03661540952357
- Version / Model
- M800727
- Company Name
- Elitechgroup Mdx LLC
- Labeler DUNS
- 117458512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-30
- Public Version
- 1
- Public Version Date
- 2022-10-10
- Public Version Status
- New
- Public Device Record Key
- ed4b50a8-b1a7-4ef0-99d0-e3a14281a867
Device Description
MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus.
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 |
|---|---|---|---|---|
| 64176 | Nucleic acid amplification primer IVD | A defined piece of single-stranded nucleic acid intended to be used to initiate the amplification of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)]. It is typically used to detect and/or identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540952357 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -10 Degrees Celsius