Liofilchem MTS (MIC Test Strip) $92108-1

GUDID 18055182872951

LIOFILCHEM SRL

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

• Primary Device ID: 18055182872951
• NIH Device Record Key: f3d0622b-600f-4a18-98a3-be4646658dee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liofilchem MTS (MIC Test Strip)
• Version Model Number: Piperacillin*- tazobactam TZP 0.016-256*
• Catalog Number: $92108-1
• Company DUNS: 435342134
• Company Name: LIOFILCHEM SRL
• Device Count: 1
• 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	08055182872954 [Primary]
GS1	18055182872951 [Package]; Contains: 08055182872954; Package: box [10 Units]; In Commercial Distribution
GS1	28055182872958 [Package]; Contains: 08055182872954; Package: box [30 Units]; In Commercial Distribution

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