FDA UDI
In Commercial Distribution
🇺🇸 United States
CellaVision® Remote Review Software, Group Edition, version independent
DI: 07350040975916
·
Model: CRRS-GR0099
·
Cellavision AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CellaVision® Remote Review Software, Group Edition, version independent
- Primary DI
- 07350040975916
- Version / Model
- CRRS-GR0099
- Catalog Number
- CRRS-GR0099
- Company Name
- Cellavision AB
- Labeler DUNS
- 508663101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-19
- Public Version
- 3
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 72732cb9-bbb7-4cb2-92ef-e15fea68b293
Device Description
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
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
- 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 |
|---|---|---|---|---|
| JOY | Device, Automated Cell-Locating | Hematology | 864.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43472 | Laboratory instrument/analyser application software IVD | An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350040975916 | GS1 |
Customer Contacts
- Phone
- +46464601600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092868 | 000 |