FDA.reportPublic FDA data

Liofilchem MIC Test Strip

Primary DI
08055182873838
Brand
Liofilchem MIC Test Strip
Company
LIOFILCHEM SRL
Model
Doxycycline DXT 0.016-256
Catalog number
$92156-10
Published
2019-09-12
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
K190914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190914000MTS Doxycycline 0.016 - 256 µg/mLLiofilchem s.r.l.2019-05-29JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055182873835PackageGS110In Commercial Distribution
08055182873838PrimaryGS10
08055182873814Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805518287383518055182873835
08055182873838080551828738388055182873838
08055182873814080551828738148055182873814

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
08056138338920Liofilchem Antibiotic DiscGepotidacin GEP 10 µg2026-08-07
08056138338937Liofilchem Antibiotic DiscGepotidacin GEP 10 µg2026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056138338920Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2026-08-07
08056138338937Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2026-08-07
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