FDA UDI
In Commercial Distribution
🇺🇸 United States
EUROPattern Microscope
DI: 04049016100560
·
Model: YG 0333-0101
·
EUROIMMUN Medizinische Labordiagnostika AG
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EUROPattern Microscope
- Primary DI
- 04049016100560
- Version / Model
- YG 0333-0101
- Company Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Labeler DUNS
- 322209263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- 6d9db651-344f-4681-a26d-859df7a231fc
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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61864 | Cell morphology analyser IVD, automated/semi-automated | An electrically-powered automated or semi-automated laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software. | No | Active |
| 67542 | Fluorescence light microscope IVD | An in vitro diagnostic magnification instrument in which light (typically ultraviolet) that has been absorbed by the specimen and re-emitted at a longer wavelength is observed (as visible light) so that the specimen is visible through the eyepiece. This device is typically used in the laboratory for histopathology and microbiology, commonly in conjunction with fluorescent dyes. Appropriate filters are used to select the correct wavelength of incoming beam to excite the fluorescent compound and eliminate the unwanted incident wavelength from the fluorescent light source (i.e., the specimen). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049016100560 | GS1 |