Kallestad

Basic Information

• Brand Name: Kallestad
• Primary DI: 00847865001564
• Version / Model: 26109
• Catalog Number: 26109
• Company Name: Bio-RAD Laboratories, Inc.
• Labeler DUNS: 844766394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: 115655e7-9452-4dcd-adca-1ecc49a13ca7

Device Description

Kallestad Crithidia luciliae 8 Well Slides

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: No
• 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
DHN	ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55049	Native DNA antibody (anti-nDNA) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865001564	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K780899	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			48 Tests
Device Size Text, specify			8 Wells

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – -20 Degrees Celsius