AccessGUDID - DEVICE: CLINITEK Status®+ Analyzer (00630414574639)

GUDID

Device Identifier (DI) Information

Brand Name: CLINITEK Status®+ Analyzer
Version or Model: 10379675
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10379675
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414574639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).

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?
57861	Urine analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care 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

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091216	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: Max 95% RH at 45'c
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d5b9cb4a-afc0-45ef-9062-d2c33fc83550
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016