FDA UDI
In Commercial Distribution
🇺🇸 United States
MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100
DI: 03661540952203
·
Model: 800350-100
·
ELITECH GROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100
- Primary DI
- 03661540952203
- Version / Model
- 800350-100
- Catalog Number
- 800350-100
- Company Name
- ELITECH GROUP INC.
- Labeler DUNS
- 079696864
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-04
- Public Version
- 1
- Public Version Date
- 2022-04-12
- Public Version Status
- New
- Public Device Record Key
- 805bbdfd-fbca-4ef0-a9d3-fe157d997b3f
Device Description
MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 region of CMV (Cytomegalovirus). QTY-100@ 480reactions.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 30798 | Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) 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 | 03661540952203 | GS1 |