AccessGUDID - DEVICE: Lipoprint System Buffer 4x16.5g (00896863002325)

GUDID

Device Identifier (DI) Information

Brand Name: Lipoprint System Buffer 4x16.5g
Version or Model: 48-9519
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 48-9519
Company Name: QUANTIMETRIX CORPORATION

Primary DI Number: 00896863002325
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 Buffer is intended to be used as an electrolyte buffer solution in conjunction with Quantimetrix Lipoprint LDL and HDL reagent kits. It is a mixture of Tris (hydroxymethyl) aminomethane and Boric Acid crystals.

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?
42693	pH-adjusted buffer solution IVD	A pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	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: 9bb61003-7b06-496e-bfc2-57a0d5e65adb
Public Version Date: October 29, 2018
Public Version Number: 1
DI Record Publish Date: September 26, 2018