FDA.report

Liofilchem MTS (MIC Test Strip)

Primary DI
08055182872145
Brand
Liofilchem MTS (MIC Test Strip)
Company
LIOFILCHEM SRL
Model
Gepotidacin GEP 0.016-256
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JWYManual Antimicrobial Susceptibility Test Systems

Product Code Classifications

CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2

Premarket Submissions

SubmissionSupplement
K260696000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K260696000MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.2026-04-17JWY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08055182872145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08055182872145080551828721458055182872145

GMDN Terms

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.

Regulatory Flags

DUNS number
435342134
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08055182872138Liofilchem MTS (MIC Test Strip)Gepotidacin GEP 0.016-2562026-05-22
08055182878567Liofilchem Antibiotic DiscCeftobiprole BPR 5 µg$92422025-07-15
18055182878571Liofilchem Antibiotic DiscCeftobiprole BPR 5 µg$9242 Cartridge2025-07-15
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
08055182870127Liofilchem MTS (MIC Test Strip)Clindamycin CD 0.016-256 100 MTS canister9207202022-01-28
08055182870158Liofilchem MTS (MIC Test Strip)TEDIZOLID TZD 0.002-32 100 MTS Canister9213602022-01-28
08055182870189Liofilchem MTS (MIC Test Strip)CEFTAZIDIME CAZ 0,016-256 100 MTS canister9213802022-01-28
08055182870219Liofilchem MTS (MIC Test Strip)TELAVANCIN TLV 0.016-256 100 MTS Canister9205302022-01-28
08055182870240Liofilchem MTS (MIC Test Strip)Delafloxacin DLX 0.002-32 100 MTS canister9208002022-01-28
08055182870271Liofilchem MTS (MIC Test Strip)ERYTHROMYCIN E 0.016-256 100 MTS canister9205102022-01-28
08055182870301Liofilchem MTS (MIC Test Strip)Meropenem-vaborbactam M/V 0.016/8-256/8 9207402022-01-28
08055182870608Liofilchem MTS (MIC Test Strip)GENTAMICIN CN 0.016-256 100 MTS canister9200902022-01-28
08055182871148Liofilchem MTS (MIC Test Strip)Ampicillin*-sulbactam AMS 0.016/0.008-256/128 100 9202702022-01-28
08055182871230Liofilchem MTS (MIC Test Strip)AZITHROMYCIN AZM 0.016-256 100 MTS canister9203002022-01-28
08055182871681Liofilchem MTS (MIC Test Strip)CIPROFLOXACIN CIP 0.002-32 100 MTS canister9204502022-01-28
08055182872169Liofilchem MTS (MIC Test Strip)Lefamulin LMU 0.016-256 100 MTS canister9206402022-01-28
08055182872282Liofilchem MTS (MIC Test Strip)Imipenem IMI 0.016-256 100 MTS canister9206802022-01-28
08055182872343Liofilchem MTS (MIC Test Strip)Plazomicin PLZ 0.016-256 100 MTS canister9207002022-01-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08055182872138Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2026-05-22
05032384569588STP8FTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2026-03-19
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05099590798980MicroScanBeckman Coulter, Inc.JWY2025-12-08
05099590798997MicroScanBeckman Coulter, Inc.JWY2025-12-08
05099590799000MicroScanBeckman Coulter, Inc.JWY2025-12-08
05099590799024MicroScanBeckman Coulter, Inc.JWY2025-12-08
03573026631994ETEST® Aztreonam Avibactam (AZA)BIOMERIEUX SAJWY2025-09-25
08055182878567Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-07-15
18055182878571Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-07-15
03573026633530ETEST® Imipenem Relebactam (IRPA)BIOMERIEUX SAJWY2025-06-23
05032384571499SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2025-04-11
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05032384580132SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2025-04-11
05032384580613SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2025-04-11
18055182873378Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2025-03-19
08055182873364Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2025-03-19
05032384571673SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-25
05032384571680SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-25
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05032384571802SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-24
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05032384571796SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-24
05032384571734SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-24
05032384544554SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-24
05032384575459SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-24
05032384571710SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDJWY2024-07-24