AccessGUDID - DEVICE: Validate (00859110005036)

GUDID

Device Identifier (DI) Information

Brand Name: Validate
Version or Model: 301db
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 301db
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00859110005036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075886031 *Terms of Use

Device Description: Validate TDM1db is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes 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?
30503	Multiple therapeutic drugs/drugs of abuse 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 therapeutic drugs and drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKB	Calibrators, Drug Mixture

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: f9371457-fbd2-4776-b694-5a824eb67626
Public Version Date: April 11, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2016