AccessGUDID - DEVICE: CLINITEK Novus® 10 Urinalysis Cassette 450 (00630414602653)

GUDID

Device Identifier (DI) Information

Brand Name: CLINITEK Novus® 10 Urinalysis Cassette 450
Version or Model: 10634643
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10634643
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414602653
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Cassette to be used on the CLINITEK Novus system for determination of 10 parameters. 450 tests guaranteed per cassette

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140717	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 492587a2-2647-481c-b6e9-b6877c7935e1
Public Version Date: November 28, 2022
Public Version Number: 7
DI Record Publish Date: September 24, 2016