BIO-RAD

Basic Information

• Brand Name: BIO-RAD
• Primary DI: 03610520014103
• Version / Model: 87530
• Catalog Number: 87530
• Company Name: BIO-RAD
• Labeler DUNS: 269902602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-03
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: f47d4b2f-052c-42d6-ae2f-52be94f8e754

Device Description

IPS

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
JRR	REGULATOR, TEMPERATURE	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64818	Microplate/tube/assay card incubator IVD	An electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. It typically consists of a heat-conducting panel/unit on which the microplate/tube/card is placed, and an electronically-controlled heating element for precise temperature control. It may also be referred to as a heater and may be used as a stand-alone device or a modular component as part of a system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03610520014103	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 each

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity