Liofilchem MTS (MIC Test Strip) $92108-10

GUDID 08055182872947

LIOFILCHEM SRL

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

• Primary Device ID: 08055182872947
• NIH Device Record Key: 5d6f4cb2-5d7f-4040-ba83-e126f2cc1ee7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liofilchem MTS (MIC Test Strip)
• Version Model Number: Piperacillin*- tazobactam TZP 0.016-256*
• Catalog Number: $92108-10
• Company DUNS: 435342134
• Company Name: LIOFILCHEM SRL
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055182872947 [Unit of Use]
GS1	08055182872961 [Primary]
GS1	18055182872944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211672

FDA Product Code

• JWY: Manual Antimicrobial Susceptibility Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-04
• Device Publish Date: 2021-10-27

On-Brand Devices [Liofilchem MTS (MIC Test Strip)]

• 18055182872180: Lefamulin LMU 0.016-256 µg/ml, 1 Strip
• 18055182872173: Lefamulin LMU 0.016-256 µg/ml, 1 Strip
• 08055182872947: Piperacillin*- tazobactam TZP 0.016-256*
• 18055182872951: Piperacillin*- tazobactam TZP 0.016-256*
• 18055182870094: MEROPENEM MRP 0.002-32 100 Strip Canister
• 18055182870063: Ceftolozane-tazobactam C/T 0.016/4 - 256/4 100 Str
• 18055182870032: VANCOMYCIN VA 0.016-256 100 Strip Canister
• 18055182870001: Dalbavancin DAL 0.002-32 100 Strip Canister
• 08055182873814: DOXYCYCLINE DXT 0.016-256 100 MTS canister
• 08055182873333: Ceftazidime-avibactam CZA 0.016/4-256/4 100 MTS ca
• 08055182873302: LINEZOLID LNZ 0.016-256 100 MTS canister
• 08055182873036: TETRACYCLINE TE 0.016-256 100 MTS canister
• 08055182872886: ERAVACYCLINE ERV 0.002-32 100 MTS canister
• 08055182872855: PENICILLIN G P 0.002-32 100 MTS canister
• 08055182872558: LEVOFLOXACIN LEV 0.002-32 100 MTS canister
• 08055182872466: Imipenem-relebactam I/R 0.002/4-32/4 1400 MTS cani
• 08055182872374: Omadacycline OMC 0.002-32 100 MTS canister
• 08055182872343: Plazomicin PLZ 0.016-256 100 MTS canister
• 08055182872282: Imipenem IMI 0.016-256 100 MTS canister
• 08055182872169: Lefamulin LMU 0.016-256 100 MTS canister
• 08055182871681: CIPROFLOXACIN CIP 0.002-32 100 MTS canister
• 08055182871230: AZITHROMYCIN AZM 0.016-256 100 MTS canister
• 08055182871148: Ampicillin*-sulbactam AMS 0.016/0.008-256/128 100
• 08055182870608: GENTAMICIN CN 0.016-256 100 MTS canister
• 08055182870301: Meropenem-vaborbactam M/V 0.016/8-256/8
• 08055182870271: ERYTHROMYCIN E 0.016-256 100 MTS canister
• 08055182870240: Delafloxacin DLX 0.002-32 100 MTS canister
• 08055182870219: TELAVANCIN TLV 0.016-256 100 MTS Canister
• 08055182870189: CEFTAZIDIME CAZ 0,016-256 100 MTS canister
• 08055182870158: TEDIZOLID TZD 0.002-32 100 MTS Canister
• 08055182870127: Clindamycin CD 0.016-256 100 MTS canister