AccessGUDID - DEVICE: Accutest (10763924710147)

GUDID

Device Identifier (DI) Information

Brand Name: Accutest
Version or Model: UA710A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JANT PHARMACAL CORPORATION

Primary DI Number: 10763924710147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 797393659 *Terms of Use

Device Description: 10-Parameter Urine Reagent Strip (glucose, bilirubin, ketone, S. G., blood, pH, protein, urobilinogen, nitrite & leukocytes)

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:	No
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?
43539	Urine catalase IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRE	Refractometer For Clinical Use
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CEN	Dye-Indicator, Ph (Urinary, Non-Quant.)
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JIO	Blood, Occult, Colorimetric, In Urine
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJX	Test, Urine Leukocyte
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052719	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21648e66-1717-43b8-abb3-17fc90ce0a02
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016