FDA UDI
In Commercial Distribution
🇺🇸 United States
NucliSENS® easyMAG®
DI: 03573026448301
·
Model: 2.1
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NucliSENS® easyMAG®
- Primary DI
- 03573026448301
- Version / Model
- 2.1
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 2
- Public Version Date
- 2021-01-25
- Public Version Status
- Update
- Public Device Record Key
- 9abd52a1-7c6e-435a-8557-16b9e9260db0
Device Description
EASYMAG SOFTWARE V2.1 : virtual reference
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJH | CLINICAL SAMPLE CONCENTRATOR | Clinical Chemistry | 862.2310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60737 | Nucleic acid sample preparation instrument IVD, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the pre-analytical preparation of samples for downstream nucleic acid amplification/analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion, nucleic acid purification, and/or nucleic acid thermal incubation. The device operates with minimal technician involvement and automation of some but not all procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026448301 | GS1 |