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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
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit FDA UDI
Device Name
The MTS™ Tetracycline 0.016-256 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Tetracycline at concentrations of 0.016-256 μg/mL should be interpreted at 16-20 hours of incubation. Tetracycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Staphylococcus aureus Acinetobacter baumannii Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae FDA UDI
Model / Reference
Tetracycline TE 0.016-256 µg/ml, 1 strip FDA UDI
Description
The MTS™ Tetracycline 0.016-256 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Tetracycline at concentrations of 0.016-256 μg/mL should be interpreted at 16-20 hours of incubation. Tetracycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Staphylococcus aureus Acinetobacter baumannii Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae FDA UDI

Identifiers

Catalog Number
$92114-1 FDA UDI
Primary DI / UDI-DI
08055182873043 FDA UDI
510(k) Number
K183140 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

No

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.

Cleared under the same submission

K183140 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 aca7f99e-2cd1-4824-9ecc-193f72ab4b51 36 fields · synced May 30, 2026