FDA UDI
In Commercial Distribution
🇺🇸 United States
ASI IVD System
DI: 07290016630039
·
Model: GenASIs 8.3
·
APPLIED SPECTRAL IMAGING LTD.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ASI IVD System
- Primary DI
- 07290016630039
- Version / Model
- GenASIs 8.3
- Company Name
- APPLIED SPECTRAL IMAGING LTD.
- Labeler DUNS
- 600741763
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-21
- Public Version
- 1
- Public Version Date
- 2022-03-29
- Public Version Status
- New
- Public Device Record Key
- f23220a8-c124-4226-a514-1764ebfbe01c
Device Description
ASI IVD System with software version GenASIs V-8.3
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 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | Hematology | 864.1860 | 2 |
| NQN | Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | Hematology | 864.1860 | 2 |
| LNJ | Analyzer, Chromosome, Automated | Hematology | 864.5260 | 2 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | Immunology | 866.4700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42838 | Laboratory analyser operation system software IVD | Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016630039 | GS1 |