← Back to catalogue

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
Erythromycin 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 Erythromycin 0.016 - 256μg/m are specialized strips impregnated with a predefined concentration gradient of Erythromycin for susceptibility testing of Staphylococcus aureus. FDA UDI
Model / Reference
Erythromycin 0.016 - 256μg/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 Erythromycin 0.016 - 256μg/m are specialized strips impregnated with a predefined concentration gradient of Erythromycin for susceptibility testing of Staphylococcus aureus. FDA UDI

Identifiers

Catalog Number
$92051-1 FDA UDI
Primary DI / UDI-DI
08055182870288 FDA UDI
510(k) Number
K172109 FDA UDI
FDA Product Code
JWY FDA UDI
GMDN Term
Erythromycin 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: Erythromycin 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 Erythromycin minimum inhibitory concentration (MIC) IVD.

Cleared under the same submission

K172109 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Liofilchem, Inc.

Sources (1)

  • FDA UDI 8baa4bf7-6a84-4b78-bdcf-aa51cc79d1d5 37 fields · synced May 29, 2026