ACCURUN® - ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 - Lgc Clinical Diagnostics, Inc.

Duns Number:106267123

Device Description: ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL

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More Product Details

Catalog Number

2010-0013

Brand Name

ACCURUN®

Version/Model Number

2010-0013

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

BK010038

Product Code Details

Product Code

KSF

Product Code Name

Kit, Quality Control For Blood Banking Reagents

Device Record Status

Public Device Record Key

545fe54a-7e4e-4959-b1ed-f31a503eb6cc

Public Version Date

March 28, 2022

Public Version Number

4

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

-

"LGC CLINICAL DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 184
2 A medical device with a moderate to high risk that requires special controls. 39