Bio-Rad Laboratories, Inc.

Basic Information

• Brand Name: Bio-Rad Laboratories, Inc.
• Primary DI: 00847865011181
• Version / Model: 25191
• Catalog Number: 25191
• 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: 6
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: a20444e5-9f00-4802-82dd-ad1013fa6ee8

Device Description

Stop Reagent for Serology EIA Tests

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
LFZ	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS	Microbiology	866.3175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58209	Phosphoric acid stop solution reagent IVD	A dilute phosphoric acid solution intended to be used to stop enzymatic activity or further development of reactions during the final processing steps of an enzyme immunoassay method, when testing clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865011181	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K954191	000

Device Sizes

Type	Value	Unit	Text
Total Volume	12	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius