BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Liofilchem Mic Test Strip (MTS)

DI: 08055182872398 · Model: Omadacycline 0.002-32 µg/mL, 10 Strip · LIOFILCHEM SRL

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

10

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Basic Information

Brand Name: Liofilchem Mic Test Strip (MTS)
Primary DI: 08055182872398
Version / Model: Omadacycline 0.002-32 µg/mL, 10 Strip
Catalog Number: $92071-10
Company Name: LIOFILCHEM SRL
Labeler DUNS: 435342134
Distribution Status: In Commercial Distribution
Device Count in Pkg: 10
Record Status: Published
Publish Date: 2019-01-31
Public Version: 2
Public Version Date: 2020-04-01
Public Version Status: Update
Public Device Record Key: 77b4131b-0f05-4b8b-b938-b74578d693c1

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
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
37300	Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit	A collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18055182872395	GS1	box	10	In Commercial Distribution
Primary	08055182872398	GS1
Unit of Use	08055182872374	GS1

Storage Conditions

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