AccessGUDID - DEVICE: QBC Diagnostics (00858092006239)

GUDID

Device Identifier (DI) Information

Brand Name: QBC Diagnostics
Version or Model: 424350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 424350
Company Name: DRUCKER DIAGNOSTICS

Primary DI Number: 00858092006239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022156957 *Terms of Use

Device Description: QBC Malaria Test System - ParaLens Advance with 60X Objective, Microscope, and Capillary Centrifuge

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
52319	Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Plasmodium (malaria parasites) in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, Differential Cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K891276	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8a062b7-c7ea-4e5f-b033-cd1f90a932ef
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016