Liofilchem Mic Test Strip (MTS) $92068-10

GUDID 18055182872302

LIOFILCHEM SRL

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
Primary Device ID18055182872302
NIH Device Record Keyba9e5004-978a-4f12-af23-b80e24e9f63e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLiofilchem Mic Test Strip (MTS)
Version Model NumberImipenem IMI 0.016-256 µg/ml 10 Strip
Catalog Number$92068-10
Company DUNS435342134
Company NameLIOFILCHEM SRL
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108055182872282 [Unit of Use]
GS108055182872305 [Primary]
GS118055182872302 [Package]
Contains: 08055182872305
Package: box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWYManual Antimicrobial Susceptibility Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-24
Device Publish Date2019-09-16

On-Brand Devices [Liofilchem Mic Test Strip (MTS)]

18055182872579MTS™ (MIC Test Strip) Levofloxacin 0.002-32 μg/mL is a quantitative method intended for the i
28055182872569MTS™ (MIC Test Strip) Levofloxacin 0.002-32 μg/mL is a quantitative method intended for the i
18055182871701The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 μg/mL is a quantitative method intended for
28055182871692The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 μg/mL is a quantitative method intended for
18055182872302Imipenem IMI 0.016-256 µg/ml 10 Strip
28055182872293Imipenem IMI 0.016-256 µg/ml, 1 Strip
18055182871169Ampicillin*-sulbactam (2/1) AMS 0.016-256*
28055182871159Ampicillin*-sulbactam (2/1) AMS 0.016-256*
18055182872388Omadacycline 0.002-32 µg/mL, 1 Strip

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