NS - This product should be used in conjunction with - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: This product should be used in conjunction with RX daytona plus reagents to dilute samples This product should be used in conjunction with RX daytona plus reagents to dilute samples prior to assay.

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More Product Details

Catalog Number

SA8396

Brand Name

NS

Version/Model Number

SA8396

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131554

Product Code Details

Product Code

JJE

Product Code Name

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device Record Status

Public Device Record Key

07bc9774-137b-4a03-8ec1-e0800c1f92aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RANDOX LABORATORIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 258