Liofilchem MTS (MIC Test Strip) - MTS is a quantitative assay for determining the - LIOFILCHEM SRL

Duns Number:435342134

Device Description: MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) 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.

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More Product Details

Catalog Number

$92103-1

Brand Name

Liofilchem MTS (MIC Test Strip)

Version/Model Number

PENICILLIN G P 0.002-32 µg/mL 1 Strip

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181889,K181889,K181889

Product Code Details

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Device Record Status

Public Device Record Key

c51687f4-6445-4b61-b1df-a3ed10815d7b

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 26, 2018

Additional Identifiers

Package DI Number

28055182872866

Quantity per Package

30

Contains DI Package

08055182872862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"LIOFILCHEM SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25