RAPIDSystems™ AutomaticQC Cartridge - for in vitro diagnostic use for multi-level - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only.

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More Product Details

Catalog Number

11046781

Brand Name

RAPIDSystems™ AutomaticQC Cartridge

Version/Model Number

11046781

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

K002738

Product Code Details

Product Code

CEM

Product Code Name

ELECTRODE, ION SPECIFIC, POTASSIUM

Device Record Status

Public Device Record Key

0d36ac11-aad4-49db-bbd2-5d793ae05be5

Public Version Date

November 19, 2021

Public Version Number

5

DI Record Publish Date

January 23, 2017

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