STANDARD™ LipidoCare Analyzer

GUDID 00887473000320

SD Biosensor, Inc.

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00887473000320
• NIH Device Record Key: 7adcc658-6403-4292-8b2a-cb1ed086d7bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STANDARD™ LipidoCare Analyzer
• Version Model Number: 02LA10G
• Company DUNS: 557812789
• Company Name: SD Biosensor, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00887473000320 [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: 2023-04-17
• Device Publish Date: 2023-04-07

On-Brand Devices [STANDARD™ LipidoCare Analyzer]

• 00887473000283: 02LA20G
• 00887473000320: 02LA10G