FDA UDI
In Commercial Distribution
🇺🇸 United States
VITEK® 2 AST-GN72
DI: 03573026530952
·
Model: VITEK® 2 AST-GN72
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VITEK® 2 AST-GN72
- Primary DI
- 03573026530952
- Version / Model
- VITEK® 2 AST-GN72
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-09
- Public Version
- 4
- Public Version Date
- 2022-05-11
- Public Version Status
- Update
- Public Device Record Key
- 13cf7d56-d817-49f8-9239-a1352dd5b8c5
Device Description
VITEK ® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli
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 |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 866.1645 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58605 | General-microorganism antimicrobial susceptibility culture medium IVD | A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03573026398491 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 03573026530952 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius