AccessGUDID - DEVICE: Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry (00630414479095)

GUDID

Device Identifier (DI) Information

Brand Name: Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry
Version or Model: 10315660
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5085
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414479095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry for use with Clintek Atlas® Urine Chemistry Analyzer

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?
54514	Multiple urine analyte IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes 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 to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021428	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
Special Storage Condition, Specify: Do not refrigerate.
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5155cbf1-ea88-4db4-a763-27abb47b6ee0
Public Version Date: November 28, 2022
Public Version Number: 7
DI Record Publish Date: September 24, 2016