AccessGUDID - DEVICE: LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3) (05055273207248)

GUDID

Device Identifier (DI) Information

Brand Name: LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3)
Version or Model: LIA3108
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273207248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays stated in this package insert.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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: 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: 1e649f1d-29a3-48de-8f45-993edcd7ea04
Public Version Date: October 13, 2022
Public Version Number: 1
DI Record Publish Date: October 05, 2022