FDA UDI
In Commercial Distribution
🇺🇸 United States
MGB Alert® Legionella Pneumophila Primer Mix ASR - 48 Reactions
DI: 03661540951190
·
Model: M800684
·
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® Legionella Pneumophila Primer Mix ASR - 48 Reactions
- Primary DI
- 03661540951190
- Version / Model
- M800684
- Catalog Number
- M800684
- Company Name
- Elitechgroup Mdx LLC
- Labeler DUNS
- 117458512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-09
- Public Version
- 2
- Public Version Date
- 2020-10-15
- Public Version Status
- Update
- Public Device Record Key
- 0f1f50e9-40da-427e-a0ae-078073c8c518
Device Description
MGB Alert® Legionella pneumophila Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Legionella pneumophila. The mix consists of a total of 9.00 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 89 bp nucleic acid sequence from the macrophage infectivity potentiator (mip) gene region of Legionella pneumophila.
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 |
|---|---|---|---|---|
| 51060 | Legionella pneumophila 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 one or multiple serogroups of Legionella pneumophila in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540951190 | GS1 |
Customer Contacts
- Phone
- 8004532725
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -10 Degrees Celsius