← 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
Ceftazidime/avibactam minimum inhibitory concentration (MIC) IVD FDA UDI
Device Name
MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime-avibactam 0.016/4 – 256 /4 µg/mL are specialized strips impregnated with a predefined concentration gradient of Ceftazidime and Avibactam for susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia Coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa. FDA UDI
Model / Reference
Ceftazidime-Avibactam 0.016/4-256/4 10 Stripsµg/mL FDA UDI
Description
MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime-avibactam 0.016/4 – 256 /4 µg/mL are specialized strips impregnated with a predefined concentration gradient of Ceftazidime and Avibactam for susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia Coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa. FDA UDI

Identifiers

Catalog Number
$92139-10 FDA UDI
Primary DI / UDI-DI
08055182873357 FDA UDI
510(k) Number
K173817 FDA UDI
FDA Product Code
JWY FDA UDI
GMDN Term
Ceftazidime/avibactam 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: Ceftazidime/avibactam 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 Ceftazidime/avibactam minimum inhibitory concentration (MIC) IVD.

Cleared under the same submission

K173817 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 09d853f5-3f91-4448-a741-80388831b5aa 37 fields · synced May 30, 2026