AccessGUDID - DEVICE: Lipoprint LDL Subfractions Kit 4x25 tests (00896863002332)

GUDID

Device Identifier (DI) Information

Brand Name: Lipoprint LDL Subfractions Kit 4x25 tests
Version or Model: 48-7002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 48-7002
Company Name: QUANTIMETRIX CORPORATION

Primary DI Number: 00896863002332
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010717890 *Terms of Use

Device Description: The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation.

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:	No
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?
31523	Total lipoprotein IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total lipoprotein lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)
JHO	Electrophoretic Separation, Lipoproteins

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010337	000
K013662	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
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: 907035e6-b24e-4670-afae-c11dd17003a7
Public Version Date: October 29, 2018
Public Version Number: 1
DI Record Publish Date: September 26, 2018