Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 00615233078575
• Version / Model: 4451
• Catalog Number: 4451
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-22
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: f0514796-6b4b-498a-a642-12a591a57555

Device Description

Manual Slide Staining Set

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIO	SLIDE STAINER, IMMERSION TYPE	Pathology	864.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42833	Microscope slide holder, preparation/staining	A holder used in the laboratory to hold microscope slides in an upright position during the preparation or staining procedures. It is typically made of plastic materials, will sit sturdily upon a flat surface (e.g., a laboratory bench top or on a shelf) and has a series of spaced slots into which the slides are placed. This is a reusable device.	No	Active
63186	Immunoassay reagent vehicle tray IVD, reusable	A removable tray designed to be loaded with an immunoassay reagent vehicle (e.g., test strip, cassette, card), after vehicle exposure to an in vitro diagnostic clinical specimen, and inserted into an immunoassay analyser. This is a reusable device.	No	Active
63042	Assay container IVD, reusable	A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures (e.g., rinsing of paraffin embedded tissues), or on-board automated liquid handling instruments or analysers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233078575	GS1

Customer Contacts

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