AccessGUDID - DEVICE: Validate (00850011135303)

GUDID

Device Identifier (DI) Information

Brand Name: Validate
Version or Model: 504ab
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 504ab
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00850011135303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075886031 *Terms of Use

Device Description: Validate Fertility 2 is intended for the quantitative determination of Calibration Verification/Linearity of 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?
54326	Progesterone 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 progesterone in a clinical specimen.	Active	false
38248	Estradiol (oestradiol) (E2) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen.	Active	false
54141	Dehydroepiandrosterone sulfate (DHEAS) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen.	Active	false
54063	Alpha-fetoprotein (AFP) 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 alpha-fetoprotein (AFP) 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: da58b36d-94cf-417b-8341-8759ca239b03
Public Version Date: February 24, 2022
Public Version Number: 2
DI Record Publish Date: March 08, 2021