FDA UDI
In Commercial Distribution
🇺🇸 United States
VITEK® REVEAL™
DI: 00860007326905
·
Model: 900-00001
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VITEK® REVEAL™
- Primary DI
- 00860007326905
- Version / Model
- 900-00001
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-09
- Public Version
- 1
- Public Version Date
- 2024-10-17
- Public Version Status
- New
- Public Device Record Key
- e8591995-1b67-4147-ad7c-a6c9c9204f19
Device Description
The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details for the Reveal Instrument are provided in this manual.
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 |
|---|---|---|---|---|
| SAN | Automated antimicrobial susceptibility test system for positive blood culture samples | Microbiology | 866.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56737 | Antimicrobial susceptibility analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of an antimicrobial susceptibility profile by monitoring the growth rate of a microbiological organism from a clinical specimen and/or culture isolate when exposed to a range ofantimicrobials. Growth detection technology used may include immunoassay, colorimetry, chromatography, photometric and/or carbon dioxide production. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007326905 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230675 | 000 |