FDA UDI
In Commercial Distribution
🇺🇸 United States
VITEK®MS
DI: 03573026626211
·
Model: VITEK MS
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VITEK®MS
- Primary DI
- 03573026626211
- Version / Model
- VITEK MS
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-08
- Public Version
- 2
- Public Version Date
- 2024-10-14
- Public Version Status
- Update
- Public Device Record Key
- f304ab8f-7c70-4cb8-80ac-681d1718e5e8
Device Description
VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument
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 |
|---|---|---|---|---|
| QBN | Mass spectrometry, MALDI TOF, microorganism identification, cultured isolates | Microbiology | 866.3378 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66836 | Mass spectrometry analyser calibration kit IVD | A collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a mass spectrometry analyser to ensure its proper function, prior to analysis/processing of clinical samples. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03573026617851 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 03573026626211 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius