FDA.reportPublic FDA data

Liofilchem MIC Test Strip (MTS)

Primary DI
08055182870202
Brand
Liofilchem MIC Test Strip (MTS)
Company
LIOFILCHEM SRL
Model
Ceftazidime 0.016-256 µg/mL 10 strips
Catalog number
$92138-10
Device description
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime 0.016-256 are specialized strips impregnated with a predefined concentration gradient of Ceftazidime for susceptibility testing of Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgarism, Pseudomonas aeruginosa
Published
2017-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K163298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163298000Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mLLiofilchem s.r.l.2017-02-22JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055182870209PackageGS110In Commercial Distribution
08055182870202PrimaryGS10
08055182870189Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805518287020918055182870209
08055182870202080551828702028055182870202
08055182870189080551828701898055182870189

GMDN Terms#

Term, Definition table
TermDefinition
Ceftazidime minimum inhibitory concentration (MIC) IVDA graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial ceftazidime, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+390858930745loredana@liofilchem.net

Regulatory Flags#

DUNS number
435342134
Device count
10
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