FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CellaVision® DM96
DI: 07350040970201
·
Model: XU-10020-01
·
Cellavision AB
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CellaVision® DM96
- Primary DI
- 07350040970201
- Version / Model
- XU-10020-01
- Catalog Number
- XU-10020-01
- Company Name
- Cellavision AB
- Labeler DUNS
- 508663101
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 5
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 3e67a2cd-22e8-48e2-b5f3-d8a1fc0afaa6
- Distribution End Date
- 2016-11-02
Device Description
Automated cell locating device. DM96 automatically locates and presents images of blood cells on peripherall blood smears.
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
- 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 |
| JOY | Device, Automated Cell-Locating | Hematology | 864.5260 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350040970201 | GS1 |
Customer Contacts
- Phone
- +46464601600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033840 | 000 |