Identity
- Trade Name
- Liofilchem MIC Test Strip (MTS) FDA UDI
- Generic Name
- Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit 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 Dalbavancin 0.002-32 μg/ml are specialized strips impregnated with a predefined concentration gradient of dalbavancin for susceptibility testing of Staphylococcus aureus and Enterococcus faecalis FDA UDI
- Model / Reference
- Dalbavancin 0.002-32 µg/ml 10 strips 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 Dalbavancin 0.002-32 μg/ml are specialized strips impregnated with a predefined concentration gradient of dalbavancin for susceptibility testing of Staphylococcus aureus and Enterococcus faecalis FDA UDI
Identifiers
- Catalog Number
- $92137-10 FDA UDI
- Primary DI / UDI-DI
- 08055182870028 FDA UDI
- 510(k) Number
- K153569 FDA UDI
- FDA Product Code
- JWY FDA UDI
- GMDN Term
- Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit 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: Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
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 Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit.
- Diamedix — Diamedix Corp. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MIC Test Strip — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MIC Test Strip (MTS) — Liofilchem, Inc. · Class II
Cleared under the same submission
K153569 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 66e7962d-2ac6-4778-b84f-f3c28a5ccdf5 37 fields · synced Jun 6, 2026