Bio-Rad Laboratories, Inc.

Basic Information

• Brand Name: Bio-Rad Laboratories, Inc.
• Primary DI: 00847865019330
• Version / Model: 12000666
• Catalog Number: 12000666
• 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: 5
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 46d14dd4-3223-4b94-b434-b7823f4568fc

Device Description

Slide Blotters, 4-well

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: No
• 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
58232	Cotton wool roll	A device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865019330	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			20 Each
Device Size Text, specify			4 wells