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Liofilchem MIC Test Strip (MTS)

FDA UDI

Class II (US FDA UDI)

by Liofilchem, Inc.

Identity

Trade Name
Liofilchem MIC Test Strip (MTS) FDA UDI
Generic Name
Linezolid 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 Linezolid 0.016 – 256 μg/mL are specialized strips impregnated with a predefined concentration gradient of Linezolid for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecium (vancomycin resistant isolates only). FDA UDI
Model / Reference
Linezolid 0.016 – 256 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 Linezolid 0.016 – 256 μg/mL are specialized strips impregnated with a predefined concentration gradient of Linezolid for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecium (vancomycin resistant isolates only). FDA UDI

Identifiers

Catalog Number
$92135-10 FDA UDI
Primary DI / UDI-DI
08055182873326 FDA UDI
510(k) Number
K180330 FDA UDI
FDA Product Code
JWY FDA UDI
GMDN Term
Linezolid 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: Linezolid 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 Linezolid minimum inhibitory concentration (MIC) IVD.

Cleared under the same submission

K180330 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Liofilchem, Inc.

Sources (1)

  • FDA UDI 8f477652-c41c-45c3-acb3-0675b780b68c 37 fields · synced Jun 8, 2026