AccessGUDID - DEVICE: Lp (a) (05055273209198)

GUDID

Device Identifier (DI) Information

Brand Name: Lp (a)
Version or Model: LP2757
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LP2757
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273209198
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Lipoprotein A IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.

FDA Product Code

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Product Code	Product Code Name
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011568	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Protect from light
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 156bdb7b-4adc-4d3a-8e23-5a09dd3ecb34
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016