AccessGUDID - DEVICE: InteliQ (03610522045914)

GUDID

Device Identifier (DI) Information

Brand Name: InteliQ
Version or Model: 12008276
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12008276
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 03610522045914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051624070 *Terms of Use

Device Description: InteliQ Specialty Immunoassay Control Level LTA (A human serum assayed immunoassay control.)

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:	Yes
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?
53594	Multiple clinical chemistry protein IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.	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: Yes 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
Storage Environment Temperature: between -70 and -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e5c8968-4bdb-4a58-b6b5-5bab824a7380
Public Version Date: January 31, 2023
Public Version Number: 2
DI Record Publish Date: September 14, 2020