Identity
- Trade Name
- Liofilchem MIC Test Strip (MTS) FDA UDI
- Generic Name
- Meropenem minimum inhibitory concentration (MIC) IVD FDA UDI
- Device Name
- MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa FDA UDI
- Model / Reference
- Meropenem 0.002-32 μg/mL 1 strip FDA UDI
- Description
- MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa FDA UDI
Identifiers
- Catalog Number
- $92084-1 FDA UDI
- Primary DI / UDI-DI
- 08055182870103 FDA UDI
- 510(k) Number
- K162854 FDA UDI
- FDA Product Code
- JWY FDA UDI
- GMDN Term
- Meropenem minimum inhibitory concentration (MIC) IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Meropenem minimum inhibitory concentration (MIC) IVD
Liofilchem MIC Test Strip (MTS) by Liofilchem, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Meropenem minimum inhibitory concentration (MIC) IVD.
- Liofilchem MIC Test Strip (MTS) — Liofilchem, Inc. · Class II
Cleared under the same submission
K162854 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Liofilchem, Inc.
Sources (1)
- FDA UDI 6809d6d0-9a10-499b-8459-c1f48c0ff27f 37 fields · synced May 30, 2026