N Protein Standard UY - Calibration of Human a1-microglobulin and - Siemens Healthcare Diagnostics Products GmbH

Duns Number:388240673

Device Description: Calibration of Human a1-microglobulin and cystatin C assays on BN Systems

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More Product Details

Catalog Number

10873632

Brand Name

N Protein Standard UY

Version/Model Number

10873632

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

K171072,K171072

Product Code Details

Product Code

JIX

Product Code Name

CALIBRATOR, MULTI-ANALYTE MIXTURE

Device Record Status

Public Device Record Key

b5efed9c-54d2-4d3e-9be6-079063965367

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

June 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 101