FDA UDI
In Commercial Distribution
🇺🇸 United States
QBC Diagnostics
DI: 00858092006000
·
Model: 429001
·
DRUCKER DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- QBC Diagnostics
- Primary DI
- 00858092006000
- Version / Model
- 429001
- Catalog Number
- 429001
- Company Name
- DRUCKER DIAGNOSTICS
- Labeler DUNS
- 022156957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1a647fc7-ad87-4943-ac4f-df15a6a9b061
Device Description
QBC STAR-M Centrifugal Hematology System: QBC STAR-M Analyzer; QBC Disposable Starter Kit (20 STAR Tubes)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 55854 | Full blood count IVD, kit, cell count | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858092006000 | GS1 | ||||
| Direct Marking | 00858092006482 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992849 | 000 |