AccessGUDID - DEVICE: AUTION™ Sticks 10EA Test Strips (00015482735265)

GUDID

Device Identifier (DI) Information

Brand Name: AUTION™ Sticks 10EA Test Strips
Version or Model: 73526
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARKRAY USA, INC.

Primary DI Number: 00015482735265
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008171162 *Terms of Use

Device Description: Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.

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?
57860	Urine analyser IVD, laboratory, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JRE	REFRACTOMETER FOR CLINICAL USE
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
LJX	TEST, URINE LEUKOCYTE
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
KQO	AUTOMATED URINALYSIS SYSTEM
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160062	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 1 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b676fcc-441b-4923-a0ae-acb206271d9f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 03, 2017