FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica Biosystems CytoVision Capture Station UG use existing Jai +CV
DI: 00849832009740
·
Model: 23CUP011CVMCVR
·
Leica Biosystems Richmond, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leica Biosystems CytoVision Capture Station UG use existing Jai +CV
- Primary DI
- 00849832009740
- Version / Model
- 23CUP011CVMCVR
- Company Name
- Leica Biosystems Richmond, Inc.
- Labeler DUNS
- 082930884
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 3
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 361f3341-a2f1-4888-822e-19a1d380b19f
Device Description
Leica Biosystems CytoVision Capture Station UG use existing Jai + CV
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
- 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 |
|---|---|---|---|---|
| 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 | 00849832009740 | GS1 |
Customer Contacts
- Phone
- +1(800)5374669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify