FDA UDI
In Commercial Distribution
🇺🇸 United States
VITEK® MS
DI: 03573026359119
·
Model: 410895
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VITEK® MS
- Primary DI
- 03573026359119
- Version / Model
- 410895
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c0d0ffb7-53f5-4ddb-a94d-feab7dc60a39
Device Description
MALDI-Tof Mass Spectrometry system used for microbial identification
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 |
|---|---|---|---|---|
| PEX | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | Microbiology | 866.3361 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61643 | Microbial identification mass spectrometry system IVD | An assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026359119 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN130013 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius