AccessGUDID - DEVICE: Liofilchem MIC Test Strip (MTS) (08055182873326)

GUDID

Device Identifier (DI) Information

Brand Name: Liofilchem MIC Test Strip (MTS)
Version or Model: Linezolid 0.016 – 256 μg/mL 10 strips
Commercial Distribution Status: In Commercial Distribution
Catalog Number: $92135-10
Company Name: LIOFILCHEM SRL

Primary DI Number: 08055182873326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 435342134 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42944	Linezolid minimum inhibitory concentration (MIC) IVD	A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial linezolid, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JWY	Manual Antimicrobial Susceptibility Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180330	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8f477652-c41c-45c3-acb3-0675b780b68c
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 09, 2018