FDA UDI
In Commercial Distribution
🇺🇸 United States
Sensititre
DI: 05032384500406
·
Model: FDANDPF
·
TREK DIAGNOSTIC SYSTEMS LIMITED
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Sensititre
- Primary DI
- 05032384500406
- Version / Model
- FDANDPF
- Company Name
- TREK DIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 298203498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-04-11
- Public Version
- 1
- Public Version Date
- 2025-04-21
- Public Version Status
- New
- Public Device Record Key
- 5679293e-2445-464a-ba0b-20e2c3468129
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
- Yes
- 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 |
|---|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Microbiology | 866.1640 | 2 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | Microbiology | 866.1640 | 2 |
| LTW | Susceptibility Test Cards, Antimicrobial | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63869 | Multiple antibacterial susceptibility testing kit IVD | A collection of reagents and other associated materials containing a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection), that may be impregnated on individual testing discs or in a strip format, intended to be used to determine the antibacterial susceptibility profile of a specific bacterial microorganism (excluding mycobateria), in a clinical specimen and/or culture isolate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05032384571574 | GS1 | ||||
| Primary | 05032384500406 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150236 | 000 |