FDA UDI
In Commercial Distribution
🇺🇸 United States
MGB Alert® HHV6 2.0 Primer Mix ASR - 48 Reactions
DI: 03661540951978
·
Model: 800499
·
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® HHV6 2.0 Primer Mix ASR - 48 Reactions
- Primary DI
- 03661540951978
- Version / Model
- 800499
- Catalog Number
- 800499
- Company Name
- Elitechgroup Mdx LLC
- Labeler DUNS
- 117458512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-08
- Public Version
- 2
- Public Version Date
- 2020-10-15
- Public Version Status
- Update
- Public Device Record Key
- 8496407c-d9bf-46a4-ac85-a279d2cd5292
Device Description
"MGB Alert® HHV-6 2.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of a total of 2.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a region of the U67 gene."
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 |
|---|---|---|---|---|
| 49743 | Human herpesvirus 6 (HHV6) 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 Human herpesvirus 6 (HHV6) 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 | 03661540951978 | GS1 |
Customer Contacts
- Phone
- 8004532725
- [email protected]