FDA UDI
In Commercial Distribution
🇺🇸 United States
Liofilchem Mic Test Strip (MTS)
DI: 08055182871155
·
Model: Ampicillin*-sulbactam (2/1) AMS 0.016-256*
·
LIOFILCHEM SRL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Liofilchem Mic Test Strip (MTS)
- Primary DI
- 08055182871155
- Version / Model
- Ampicillin*-sulbactam (2/1) AMS 0.016-256*
- Catalog Number
- $92027-1
- Company Name
- LIOFILCHEM SRL
- Labeler DUNS
- 435342134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-06
- Public Version
- 1
- Public Version Date
- 2019-12-16
- Public Version Status
- New
- Public Device Record Key
- 894ce334-67f3-454e-b431-ba3973df9521
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37300 | Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit | A collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28055182871159 | GS1 | BOX | 30 | In Commercial Distribution | |
| Primary | 08055182871155 | GS1 | ||||
| Package | 18055182871152 | GS1 | BOX | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192345 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – Degrees Celsius