AccessGUDID - DEVICE: Pointe Lipoprotein (a) Control Set (00811727015594)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Lipoprotein (a) Control Set
Version or Model: L7597-CTL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L7597-CTL
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727015594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For in vitro diagnostic use.

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):	Yes
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?
41418	Lipoprotein A IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131556	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: 488cf5c1-c39e-4fc9-9d64-7eea6fc74625
Public Version Date: February 08, 2021
Public Version Number: 1
DI Record Publish Date: January 30, 2021