FDA UDI
In Commercial Distribution
🇺🇸 United States
VITEK®2
DI: 03573026553968
·
Model: 8.01
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VITEK®2
- Primary DI
- 03573026553968
- Version / Model
- 8.01
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-03
- Public Version
- 5
- Public Version Date
- 2019-03-11
- Public Version Status
- Update
- Public Device Record Key
- 139719b1-7b5c-49a6-91af-d1ba2778454b
Device Description
VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
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
- 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 |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 866.1645 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56748 | Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated | An electrically-powered laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026553968 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103752 | 000 |