Liofilchem MIC Test Strip (MTS)

Basic Information

• Brand Name: Liofilchem MIC Test Strip (MTS)
• Primary DI: 08055182870226
• Version / Model: Telavancin 0.016-256 µg/mL 1 strip
• Catalog Number: $92053-1
• Company Name: LIOFILCHEM SRL
• Labeler DUNS: 435342134
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ec5a0931-34a4-4c1a-90c8-8698f25e39ee

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 Telavancin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Telavancin for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecalis (vancomycin-susceptible isolates only).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62037	Telavancin minimum inhibitory concentration (MIC) IVD	A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial telavancin, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28055182870220	GS1	box	30	In Commercial Distribution
Primary	08055182870226	GS1
Package	18055182870223	GS1	box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K163517	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius