AccessGUDID - DEVICE: pts panels® HDL Cholesterol Controls (00381930722010)

GUDID

Device Identifier (DI) Information

Brand Name: pts panels® HDL Cholesterol Controls
Version or Model: 722
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 722
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381930722010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with each set of controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.

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:	No
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?
44695	High density lipoprotein (HDL) cholesterol IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022401	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: Do not freeze.
Special Storage Condition, Specify: Use care not to contaminate dropper tip.
Special Storage Condition, Specify: Product is ready to use and is clear.
Special Storage Condition, Specify: Recap after using.
Special Storage Condition, Specify: Opened product is stable for at least ten months at room temperature.
Special Storage Condition, Specify: Do not use beyond the expiration date on the vial.
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 20 and 30 Degrees Celsius
Storage Environment Temperature: between 68 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 35 and 46 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28fcfc11-ff68-43cb-96b7-93186cc88f86
Public Version Date: January 23, 2023
Public Version Number: 4
DI Record Publish Date: September 18, 2018