AccessGUDID - DEVICE: AUTION™ MAX AX-4022 Analyzer (00015482129743)

GUDID

Device Identifier (DI) Information

Brand Name: AUTION™ MAX AX-4022 Analyzer
Version or Model: 102974
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARKRAY USA, INC.

Primary DI Number: 00015482129743
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008171162 *Terms of Use

Device Description: Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.

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:	No
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
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JRE	REFRACTOMETER FOR CLINICAL USE
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE
KQO	AUTOMATED URINALYSIS SYSTEM
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
LJX	TEST, URINE LEUKOCYTE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d5aeb679-7a4a-4156-a083-276cb8310d43
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 03, 2017