FDA UDI
In Commercial Distribution
🇺🇸 United States
dIFine Automated Microscope
DI: 08059304340109
·
Model: dIFine Automated Microscope
·
VISIA LAB SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- dIFine Automated Microscope
- Primary DI
- 08059304340109
- Version / Model
- dIFine Automated Microscope
- Company Name
- VISIA LAB SRL
- Labeler DUNS
- 441255829
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-07
- Public Version
- 3
- Public Version Date
- 2024-11-11
- Public Version Status
- Update
- Public Device Record Key
- 22378efa-871c-4860-92a7-3c2a7a7382af
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | Immunology | 866.4750 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36225 | Scanning laser optical microscope | A microscope designed to obtain high-magnification cross-sectional [three-dimensional (3-D)] images by scanning the sample with the focused point of laser light, restricting the illumination to a tiny, targeted section of the specimen while eliminating out-of-focus light (confocal microscopy). The image data is detected, amplified, and usually digitized and displayed on a high resolution (typically 1024 x 1024 pixel) monitor. The data can be stored, e.g., in a computer. This microscope can be mounted on conventional or specially designed light microscopes, e.g., upright or inverted stage, and is mostly used for cell and molecular biology examinations, e.g., cells, cell cultures or tissue. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08059304340109 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201956 | 000 |