FDA UDI
In Commercial Distribution
🇺🇸 United States
QBC Diagnostics
DI: 00858092006314
·
Model: 424346
·
DRUCKER DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QBC Diagnostics
- Primary DI
- 00858092006314
- Version / Model
- 424346
- Catalog Number
- 424346
- Company Name
- DRUCKER DIAGNOSTICS
- Labeler DUNS
- 022156957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fad446fa-94cc-49bf-8862-0f60cd2d15c1
Device Description
ParaLens Advance with 40X & 100X Objectives
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16438 | Microscope light source | A mains electricity (AC-powered) device that is exclusively designed to provide a microscope with an external source of light to light up the viewing field which may be, e.g., directly under the magnification system (a slide) or a field of surgical intervention. This device may be a simple lamp, or utilize fibreoptic cables to carry a cold light forward to the site. This device is not built into the microscope and must be identified using this GMDN code. If the light source is built-in, then it shall be considered as part of the parent device and the product identification will then follow that of the parent device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858092006314 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K891276 | 000 |