AccessGUDID - DEVICE: CHECK UP AMERICA CHOLESTEROL PANEL (M769CHOLESTEROL801)

GUDID

Device Identifier (DI) Information

Brand Name: CHECK UP AMERICA CHOLESTEROL PANEL
Version or Model: 80
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Home Access Health Corporation

Primary DI Number: M769CHOLESTEROL801
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 848511283 *Terms of Use

Device Description: Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.

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):	Yes
Over the Counter (OTC):	Yes
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?
38092	Capillary blood collection set, home-use	A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory); some types may be in the form of a self-contained unit featuring a suction mechanism. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063852	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e491e8f-3c11-44e5-b13d-7b4a34133b78
Public Version Date: June 09, 2025
Public Version Number: 6
DI Record Publish Date: September 09, 2016