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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
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit FDA UDI
Model / Reference
Plazomicin PLZ 0.016-256 100 MTS canister FDA UDI

Identifiers

Catalog Number
920700 FDA UDI
Primary DI / UDI-DI
18055182872340 FDA UDI
510(k) Number
K181708 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 MTS (MIC Test Strip) 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

K181708 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 a234179c-9595-403b-9860-d3de287a133e 34 fields · synced May 30, 2026