AccessGUDID - DEVICE: CURO L7 Lipid Test Strip - Lipid Profile (08809319396512)

GUDID

Device Identifier (DI) Information

Brand Name: CURO L7 Lipid Test Strip - Lipid Profile
Version or Model: 99LS10-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SD Biosensor, Inc.

Primary DI Number: 08809319396512
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 557812789 *Terms of Use

Device Description: No description.

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):	Yes
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?
52850	Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CHH	Enzymatic Esterase--Oxidase, Cholesterol
JGY	Colorimetric Method, Triglycerides
LBR	Ldl & Vldl Precipitation, Hdl

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160282	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: 00d7c67e-d212-4e0d-9b68-4c83e74253e0
Public Version Date: April 29, 2020
Public Version Number: 1
DI Record Publish Date: April 21, 2020