The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Siemens Healthcare Diagnostics Reagent Strips for Urinalysis, such as Multistix® 10 SG and Multistix PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine ratio, Specific Gravity, and Urobilinogen.

The CLINITEK Advantus urinalysis analyzer is a semi
CLINITEK Advantus® Analyzer - 10636672

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JIO

Device Name: Blood, Occult, Colorimetric, In Urine

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.6550

Third Party Flag: Y

Medical Specialty: HE

Code: JIR

Device Name: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1645

Third Party Flag: N

Medical Specialty: CH

Code: KQO

Device Name: Automated Urinalysis System

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2900

Third Party Flag: N

Medical Specialty: CH

Code: JIL

Device Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1340

Third Party Flag: Y

Medical Specialty: CH

Code: JRE

Device Name: Refractometer For Clinical Use

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2800

Third Party Flag: N

Medical Specialty: CH

Code: CDM

Device Name: Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1785

Third Party Flag: N

Medical Specialty: CH

Code: JIN

Device Name: Nitroprusside, Ketones (Urinary, Non-Quant.)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1435

Third Party Flag: N

Medical Specialty: CH

Code: JJB

Device Name: Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1115

Third Party Flag: N

Medical Specialty: CH

Code: CEN

Device Name: Dye-Indicator, Ph (Urinary, Non-Quantitative)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1550

Third Party Flag: N

Medical Specialty: CH

Code: LJX

Device Name: Test, Urine Leukocyte

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.7675

Third Party Flag: N

Medical Specialty: HE

Code: JFY

Device Name: Enzymatic Method, Creatinine

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1225

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00630414593562

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A