Sure-Vue

Basic Information

• Brand Name: Sure-Vue
• Primary DI: 00613647000311
• Version / Model: 23-200-278
• Catalog Number: 23200278
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• Labeler DUNS: 004321519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5aac1faa-05ca-4fad-8fd3-4362af3c2ea2

Device Description

Sure-Vue Signature Cryptosporidium and Giardia Control Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JTR	KIT, QUALITY CONTROL FOR CULTURE MEDIA	Microbiology	866.2480	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47360	Multiple faecal parasite antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20613647000315	GS1		64	In Commercial Distribution
Primary	00613647000311	GS1

Customer Contacts

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