Multistix® Reagent Strips - Siemens Healthcare Diagnostics Reagent Strips for - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

A2179B16

Brand Name

Multistix® Reagent Strips

Version/Model Number

10339953

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K992257,K992257

Product Code Details

Product Code

CDM

Product Code Name

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

Device Record Status

Public Device Record Key

8fe6ec7d-1c46-44bd-80c4-8c8154661ff4

Public Version Date

December 22, 2021

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