BRT Liquid Assayed Chemistry Control with CRP 100-9020

GUDID EABA10090200

BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert for the Abaxis Piccolo Express®.

Bioresource Technology

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: EABA10090200
• NIH Device Record Key: d8a8c32e-32fd-4a4e-9601-b7a7c1291408
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRT Liquid Assayed Chemistry Control with CRP
• Version Model Number: 100-9020
• Catalog Number: 100-9020
• Company DUNS: 928908037
• Company Name: Bioresource Technology
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EABA10090200 [Unit of Use]
HIBCC	EABA10090201 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01

Devices Manufactured by Bioresource Technology

• EABA10090100 - BRT Liquid Assayed Chemistry Control: 2021-04-09 BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for t
• EABA10090110 - BRT Verification Samples: 2021-04-09 BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.
• EABA10090200 - BRT Liquid Assayed Chemistry Control with CRP: 2021-04-09BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert for the Abaxis Piccolo Express®.
• EABA10090200 - BRT Liquid Assayed Chemistry Control with CRP: 2021-04-09 BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for t
• EABA10090210 - BRT Verification Samples with CRP: 2021-04-09 BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.