AccessGUDID - DEVICE: CLINITEK Novus® Automated Urine Chemistry Analyzer (00630414981130)

GUDID

Device Identifier (DI) Information

Brand Name: CLINITEK Novus® Automated Urine Chemistry Analyzer
Version or Model: 10494134
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10494134
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414981130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu

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?
35918	Urine analyser IVD, laboratory	An electrically-powered automated or semi-automated 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.	Active	false

FDA Product Code

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

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 -20 and 65 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 126450af-7585-460d-a243-39ed020ef002
Public Version Date: September 16, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016