Lp(a) CAL SET - This product is intended for use in the - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: This product is intended for use in the calibration of Lipoprotein(a) assays.

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More Product Details

Catalog Number

LP3404

Brand Name

Lp(a) CAL SET

Version/Model Number

LP3404

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

K011568

Product Code Details

Product Code

JIS

Product Code Name

Calibrator, Primary

Device Record Status

Public Device Record Key

d3655da4-41eb-449c-b9aa-66aece9a7521

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 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