AccessGUDID - DEVICE: Validate (00850011135716)

GUDID

Device Identifier (DI) Information

Brand Name: Validate
Version or Model: 408re
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 408re
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00850011135716
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075886031 *Terms of Use

Device Description: VALIDATE Tumor Markers 2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: CYFRA 21-1 Set: Cytokeratin 19 Fragment (CYFRA 21-1). HE4 Set: Human Epididymal Protein 4 (HE4). VALIDATE Test Kits are non-automated and intended for laboratory professional use only.

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?
56657	Human epididymis protein 4 (HE4) 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 human epididymis protein 4 (HE4) ovarian cancer marker, in a clinical specimen.	Active	false
38177	Cytokeratin 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 one or multiple cytokeratin subtype(s) 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: 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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 tests

Device Record Status

Public Device Record Key: 5d29a961-1649-4e19-aaa5-a7011c03a4b9
Public Version Date: September 13, 2024
Public Version Number: 1
DI Record Publish Date: September 05, 2024