AccessGUDID - DEVICE: Liofilchem Mic Test Strip (MTS) (08055182873357)

GUDID

Device Identifier (DI) Information

Brand Name: Liofilchem Mic Test Strip (MTS)
Version or Model: Ceftazidime-Avibactam 0.016/4-256/4 10 Stripsµg/mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: $92139-10
Company Name: LIOFILCHEM SRL

Primary DI Number: 08055182873357
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 435342134 *Terms of Use

Device Description: MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime-avibactam 0.016/4 – 256 /4 µg/mL are specialized strips impregnated with a predefined concentration gradient of Ceftazidime and Avibactam for susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia Coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa.

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?
62580	Ceftazidime/avibactam minimum inhibitory concentration (MIC) IVD	A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobials ceftazidime and avibactam, 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 [?]
K173817	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: less than -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 09d853f5-3f91-4448-a741-80388831b5aa
Public Version Date: July 09, 2018
Public Version Number: 1
DI Record Publish Date: June 08, 2018