BRT Verification Samples

Basic Information

• Brand Name: BRT Verification Samples
• Primary DI: EABA10090111
• Version / Model: 100-9011
• Catalog Number: 100-9011
• Company Name: Bioresource Technology
• Labeler DUNS: 928908037
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2021-04-01
• Public Version: 1
• Public Version Date: 2021-04-09
• Public Version Status: New
• Public Device Record Key: cf51f205-0765-4085-93f0-da49787a0f7d

Device Description

BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.

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: 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
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47869	Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	EABA10090110	HIBCC
Primary	EABA10090111	HIBCC