AccessGUDID - DEVICE: Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System (10673486000498)

GUDID

Device Identifier (DI) Information

Brand Name: Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System
Version or Model: TC-720+
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TC-720+
Company Name: TECO DIAGNOSTICS

Primary DI Number: 10673486000498
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185067774 *Terms of Use

Device Description: Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System consists of the Uritek TC-720+ Urine Analyzer and the Teco Diagnostics Urine Reagent Strips (URS-10). The Uritek TC-720+ Urine Analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent Strips (URS-10) as a system for the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)
JIO	Blood, Occult, Colorimetric, In Urine
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
JRE	Refractometer For Clinical Use
KQO	Automated Urinalysis System
LIX	Aid, Cardiopulmonary Resuscitation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051526	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 0 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 522a4685-5cae-4728-ac52-24f7e079c374
Public Version Date: June 13, 2024
Public Version Number: 1
DI Record Publish Date: June 05, 2024