AccessGUDID - DEVICE: Validate (00850011135181)

GUDID

Device Identifier (DI) Information

Brand Name: Validate
Version or Model: 901re
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901re
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00850011135181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075886031 *Terms of Use

Device Description: Validate THY is intended for the 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?
54127	Total cortisol 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 total cortisol in a clinical specimen.	Active	false
58325	Total thyroxine (TT4) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen.	Active	false
38258	Free thyroxine (FT4) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen.	Active	false
38271	Thyroid stimulating hormone (TSH) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen.	Active	false
58334	Total triiodothyronine (TT3) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen.	Active	false
54418	Free triiodothyronine (FT3) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of free triiodothyronine (FT3) 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 -25 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 tests

Device Record Status

Public Device Record Key: e7b3137e-bfd5-4726-b3d1-77efe0c57465
Public Version Date: March 07, 2023
Public Version Number: 3
DI Record Publish Date: March 02, 2020