FDA UDI
In Commercial Distribution
🇺🇸 United States
VITEK® REVEAL™ BC GN02-AST
DI: 03573026638887
·
Model: VITEK® REVEAL™ BC GN02-AST
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- VITEK® REVEAL™ BC GN02-AST
- Primary DI
- 03573026638887
- Version / Model
- VITEK® REVEAL™ BC GN02-AST
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-10-09
- Public Version
- 2
- Public Version Date
- 2025-07-22
- Public Version Status
- Update
- Public Device Record Key
- 4773f98a-f0d8-4be0-b9da-8d939f316da9
Device Description
VITEK REVEAL BC GN02-AST is an antibiotic panel (20 panels/box)
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 63834 | Antibacterial susceptibility testing disc IVD | A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 03573026638894 | GS1 | ||||
| Primary | 03573026638887 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230675 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius