AccessGUDID - DEVICE: Urine Uric Acid Standard Kit (00852553007032)

GUDID

Device Identifier (DI) Information

Brand Name: Urine Uric Acid Standard Kit
Version or Model: 9020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VERICHEM LABORATORIES, INC.

Primary DI Number: 00852553007032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 189023351 *Terms of Use

Device Description: calibrator / calibration verifier

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):	No
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?
53593	Multiple clinical chemistry protein IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	Calibrator, Multi-Analyte Mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112834	000

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 -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 25 Milliliter

Device Record Status

Public Device Record Key: 3fbe5374-abb8-4674-ba89-5af48a23ec59
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 29, 2016