FDA.reportPublic FDA data

Liofilchem Mic Test Strip (MTS)

Primary DI
08055182871698
Brand
Liofilchem Mic Test Strip (MTS)
Company
LIOFILCHEM SRL
Model
Ciprofloxacin CIP 0.002-32 μg/mL 1 Strip
Catalog number
$92045-1
Device description
The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.The MTS™ Ciprofloxacin at concentrations of 0.002-32 μg/mL should be interpreted at 16-20 hours of incubation.MTS™ Ciprofloxacin can be used to determine the MIC of ciprofloxacin against the following bacteria.Ciprofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:Gram-negative bacteriaCitrobacter freundiiCitrobacter koseriEnterobacter cloacaeEscherichia coliKlebsiella pneumoniaeMorganella morganiiProteus mirabilisProteus vulgarisProvidencia rettgeriProvidencia stuartiiPseudomonas aeruginosaSerratia marcescens
Published
2019-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JWYManual Antimicrobial Susceptibility Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183527000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183527000MTS Ciprofloxacin 0.002 - 32 µg/mLLiofilchem s.r.l.2019-03-19JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055182871695PackageGS110In Commercial Distribution
28055182871692PackageGS130In Commercial Distribution
08055182871698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805518287169518055182871695
2805518287169228055182871692
08055182871698080551828716988055182871698

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kitA collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
435342134
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055182872138Liofilchem MTS (MIC Test Strip)Gepotidacin GEP 0.016-2562026-05-22
08055182872145Liofilchem MTS (MIC Test Strip)Gepotidacin GEP 0.016-2562026-05-22
08058951161426Liofilchem Mic Test Strip (MTS)Aztreonam-avibactam AZA 0.016/4-256/42026-01-12
08058951161433Liofilchem Mic Test Strip (MTS)Aztreonam-avibactam AZA 0.016/4-256/42026-01-12
08058951161266Liofilchem Mic Test Strip (MTS)Sulbactam-durlobactam SUD 0.004/4-64/42025-11-03
08058951161273Liofilchem Mic Test Strip (MTS)Sulbactam-durlobactam SUD 0.004/4-64/42025-11-03
08058951161310Liofilchem Antibiotic DiscSulopenem SPM 2 µg2025-11-03
08058951161327Liofilchem Antibiotic DiscSulopenem SPM 2 µg2025-11-03
08055182878574Liofilchem Antibiotic DiscCeftobiprole BPR 5 µg$9242 Cartridge2025-07-15
08055182878567Liofilchem Antibiotic DiscCeftobiprole BPR 5 µg$92422025-07-15
18055182878571Liofilchem Antibiotic DiscCeftobiprole BPR 5 µg$9242 Cartridge2025-07-15
08055182873371Liofilchem MTS (MIC Test Strip)Ceftobiprole 0.002-32 µg/mL, 1 Strip$92140-12025-03-19
18055182873361Liofilchem MTS (MIC Test Strip)Ceftobiprole 0.002-32 µg/mL, 1 Strip9214002025-03-19
18055182873378Liofilchem MTS (MIC Test Strip)Ceftobiprole 0.002-32 µg/mL, 1 Strip$92140-12025-03-19
08055182873364Liofilchem MTS (MIC Test Strip)Ceftobiprole 0.002-32 µg/mL, 1 Strip9214002025-03-19
08058951160436ComASP ComASP Cefiderocol 0.008-12875009U2023-05-31
18055182870124Liofilchem MTS (MIC Test Strip)Clindamycin CD 0.016-256 100 MTS canister9207202022-01-28
18055182870155Liofilchem MTS (MIC Test Strip)TEDIZOLID TZD 0.002-32 100 MTS Canister9213602022-01-28
18055182870186Liofilchem MTS (MIC Test Strip)CEFTAZIDIME CAZ 0,016-256 100 MTS canister9213802022-01-28
18055182870216Liofilchem MTS (MIC Test Strip)TELAVANCIN TLV 0.016-256 100 MTS Canister9205302022-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08058951161426Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2026-01-12
08058951161433Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2026-01-12
15099590798970MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.JWY2025-12-08
08058951161266Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2025-11-03
08058951161273Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2025-11-03
08058951161310Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-11-03
08058951161327Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-11-03
08055182878574Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-07-15
08055182873371Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2025-03-19
18055182873361Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2025-03-19
00848838036835SENSITITRE YEASTONE SUSCEPTIBILITY PLATESREMEL, INC.JWY2023-06-20
00848838074530Sensititire® OptiRead™REMEL, INC.JWY2023-06-20
00848838097409THE SENSITITRE AIMREMEL, INC.JWY2023-06-20
15099590765361MicroScanBeckman Coulter, Inc.JWY2022-08-01
15099590765378MicroScanBeckman Coulter, Inc.JWY2022-08-01
15099590765385MicroScanBeckman Coulter, Inc.JWY2022-08-01
18055182870124Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870155Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870186Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870216Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870247Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870278Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870308Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870605Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182871145Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28