FDA UDI
In Commercial Distribution
🇺🇸 United States
Liofilchem MIC Test Strip
DI: 08055182871254
·
Model: Azithromycin 0.016-256 µg/mL 10 Strips
·
LIOFILCHEM SRL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Liofilchem MIC Test Strip
- Primary DI
- 08055182871254
- Version / Model
- Azithromycin 0.016-256 µg/mL 10 Strips
- Catalog Number
- $92030-10
- Company Name
- LIOFILCHEM SRL
- Labeler DUNS
- 435342134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-06-08
- Public Version
- 1
- Public Version Date
- 2018-07-09
- Public Version Status
- New
- Public Device Record Key
- caea40f7-7200-4b4c-8d0d-ef1080fe8e9d
Device Description
MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Azithromycin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Azithromycin for susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains)
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 |
|---|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43604 | Azithromycin minimum inhibitory concentration (MIC) IVD | A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial azithromycin, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18055182871251 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 08055182871254 | GS1 | ||||
| Unit of Use | 08055182871230 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180339 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 8 Degrees Celsius