CLINITEK Advantus® Analyzer - The CLINITEK Advantus urinalysis analyzer is a - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is d 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.

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More Product Details

Catalog Number

1420US

Brand Name

CLINITEK Advantus® Analyzer

Version/Model Number

10636672

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K063276

Product Code Details

Product Code

CDM

Product Code Name

DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Device Record Status

Public Device Record Key

09195209-b04d-4fa1-ae7a-e6c5021f7c44

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 363
2 A medical device with a moderate to high risk that requires special controls. 829
3 A medical device with high risk that requires premarket approval 57
U Unclassified 7