Q-Slide™

Basic Information

• Brand Name: Q-Slide™
• Primary DI: 00819398028707
• Version / Model: Z302
• Catalog Number: Z302
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-08-07
• Public Version: 1
• Public Version Date: 2020-08-17
• Public Version Status: New
• Public Device Record Key: 2fff95d8-982b-4a82-9076-ce45c6da1a79

Device Description

Q-Slide™ Gram, a prepared control slide for the QC of the gram stain, has E. coli and S. aureus, pre-inoculated, 5 slides per box A convenient ready-to-stain control slide that will test both your stain solutions and your staining techniques. Positive and negative stain control organisms are affixed to the circles in each Q-Slide™. Up to four patient specimens (in the squares) may be processed at the same time as the QC organisms.

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: Yes
• 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
LJG	Quality Control Slides	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43510	Biological stain control IVD	A prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398027533	GS1
Primary	00819398028707	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius