AccessGUDID - DEVICE: Validate (00850011135358)

GUDID

Device Identifier (DI) Information

Brand Name: Validate
Version or Model: 705ab
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 705ab
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00850011135358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075886031 *Terms of Use

Device Description: Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.

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?
30219	Multiple urine analyte 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 semi-quantitative screening of urine for multiple analytes.	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
Storage Environment Temperature: between -25 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 tests

Device Record Status

Public Device Record Key: d42bd311-5564-4d00-a5c4-55dc9e022951
Public Version Date: February 24, 2022
Public Version Number: 2
DI Record Publish Date: June 28, 2021