AccessGUDID - DEVICE: BRT Liquid Assayed Chemistry Control with CRP (EABA10090201)

GUDID

Device Identifier (DI) Information

Brand Name: BRT Liquid Assayed Chemistry Control with CRP
Version or Model: 100-9020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100-9020
Company Name: Bioresource Technology

Primary DI Number: EABA10090201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 928908037 *Terms of Use

Device Description: 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®.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8a8c32e-32fd-4a4e-9601-b7a7c1291408
Public Version Date: April 09, 2021
Public Version Number: 1
DI Record Publish Date: April 01, 2021