FDA.reportPublic FDA data

Liofilchem Antibiotic Disc

Primary DI
18055182878571
Brand
Liofilchem Antibiotic Disc
Company
LIOFILCHEM SRL
Model
Ceftobiprole BPR 5 µg
Catalog number
$9242 Cartridge
Published
2025-07-15
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

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
K250885000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250885000Ceftobiprole BPR 5 µg DiscLiofilchem, Inc.2025-06-23JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055182878571PackageGS15In Commercial Distribution
08055182878574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805518287857118055182878571
08055182878574080551828785748055182878574

GMDN Terms#

Term, Definition table
TermDefinition
Antibacterial susceptibility testing disc IVDA susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.

Sterilization Methods#

Method table
Method

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 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
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
18055182870247Liofilchem MTS (MIC Test Strip)Delafloxacin DLX 0.002-32 100 MTS canister9208002022-01-28

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