DEVICE: dIFine Automated Microscope (08059304340109)
Device Identifier (DI) Information
dIFine Automated Microscope
dIFine Automated Microscope
In Commercial Distribution
VISIA LAB SRL
dIFine Automated Microscope
In Commercial Distribution
VISIA LAB SRL
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use |
DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K201956 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
22378efa-871c-4860-92a7-3c2a7a7382af
November 11, 2024
3
September 07, 2022
November 11, 2024
3
September 07, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined