AccessGUDID - DEVICE: Chemcard Cholesterol (00737051548303)

GUDID

Device Identifier (DI) Information

Brand Name: Chemcard Cholesterol
Version or Model: 43001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHEMATICS, INC.

Primary DI Number: 00737051548303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196929947 *Terms of Use

Device Description: The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only.

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):	No
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?
61963	Multiple lipid analyte IVD, kit, colorimetric, rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL) and low density lipoprotein (LDL)] to generate a lipid profile, within a short period of time relative to standard laboratory testing procedures, using a colorimetric method. This test is commonly used in the laboratory or in point-of-care analyses to screen patients at risk of developing coronary artery disease and/or lipid metabolism disorders. It is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CHH	Enzymatic Esterase--Oxidase, Cholesterol

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K864159	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: less than 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b4b86a7b-00d8-42ef-9c85-2deee67e0390
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016