AccessGUDID - DEVICE: Liofilchem MIC Test Strip (MTS) (08055182870011)

GUDID

Device Identifier (DI) Information

Brand Name: Liofilchem MIC Test Strip (MTS)
Version or Model: Dalbavancin 0.002-32 µg/ml 1 strip
Commercial Distribution Status: In Commercial Distribution
Catalog Number: $92137-1
Company Name: LIOFILCHEM SRL

Primary DI Number: 08055182870011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
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 Dalbavancin 0.002-32 μg/ml are specialized strips impregnated with a predefined concentration gradient of dalbavancin for susceptibility testing of Staphylococcus aureus and Enterococcus faecalis

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWY	Manual Antimicrobial Susceptibility Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153569	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: 8aaa8dc7-d387-4b18-992a-5345e0b090e4
Public Version Date: January 23, 2019
Public Version Number: 4
DI Record Publish Date: January 31, 2017