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Liofilchem MTS (MIC Test Strip)

FDA UDI

Class II (US FDA UDI)

by Liofilchem, Inc.

Identity

Trade Name
Liofilchem MTS (MIC Test Strip) FDA UDI
Generic Name
Penicillin G minimum inhibitory concentration (MIC) IVD FDA UDI
Device Name
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp. FDA UDI
Model / Reference
PENICILLIN G P 0.002-32 µg/mL 1 Strip FDA UDI
Description
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp. FDA UDI

Identifiers

Catalog Number
$92103-1 FDA UDI
Primary DI / UDI-DI
08055182872862 FDA UDI
510(k) Number
K181889 FDA UDI
FDA Product Code
JWY FDA UDI
GMDN Term
Penicillin G 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

Yes

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: Penicillin G minimum inhibitory concentration (MIC) IVD

Liofilchem MTS (MIC Test Strip) by Liofilchem, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Penicillin G minimum inhibitory concentration (MIC) IVD.

Cleared under the same submission

K181889 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 c51687f4-6445-4b61-b1df-a3ed10815d7b 36 fields · synced Jun 1, 2026