STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile

GUDID 00887473000313

SD Biosensor, Inc.

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00887473000313
• NIH Device Record Key: 7cc97326-510b-42af-809e-24d95fcfce53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile
• Version Model Number: 02LS10B
• Company DUNS: 557812789
• Company Name: SD Biosensor, Inc.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887473000290 [Primary]
GS1	00887473000306 [Primary]
GS1	00887473000313 [Unit of Use]
GS1	00887473000337 [Primary]
GS1	00887473000344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160282

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-27
• Device Publish Date: 2023-03-17

Devices Manufactured by SD Biosensor, Inc.

• 00887473000320 - STANDARD™ LipidoCare Analyzer: 2023-04-17
• 00887473000283 - STANDARD™ LipidoCare Analyzer: 2023-03-27
• 00887473000313 - STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile: 2023-03-27
• 00887473000313 - STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile: 2023-03-27
• 08809319396161 - CURO L7 Analyzer: 2020-05-12
• 00887473000009 - SD GlucoNavii Blood Glucose Monitoring System: 2018-07-06
• 00887473000016 - SD GlucoNavii Blood Glucose Monitoring System: 2018-07-06
• 00887473000108 - SD GlucoNavii Blood Glucose Monitoring System: 2018-07-06
• 0887473000115 - SD GlucoNavii Blood Glucose Test Strip: 2018-07-06