AccessGUDID - DEVICE: Mercodia Lp(a) ELISA (07350108630016)

GUDID

Device Identifier (DI) Information

Brand Name: Mercodia Lp(a) ELISA
Version or Model: 10-1106-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-1106-01
Company Name: Mercodia AB

Primary DI Number: 07350108630016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354553091 *Terms of Use

Device Description: Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in 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):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64682	Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A, also known as Lp(a) lipid, in a clinical specimen using an enzyme immunoassay (EIA) method. Lp(a) levels are typically used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSJ	Apolipoproteins

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 98e9d6f4-5318-486e-89b0-d1110e7ab188
Public Version Date: April 16, 2020
Public Version Number: 1
DI Record Publish Date: April 08, 2020