iFlash 9000 CLIA Analyzer FG0076

GUDID 06925912715221

Type A, Standard

Shenzhen YHLO Biotech Co., Ltd.

Chemiluminescent immunoassay analyser IVD

• Primary Device ID: 06925912715221
• NIH Device Record Key: f147047f-ad8d-4269-9ff1-bb28e7f82b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFlash 9000 CLIA Analyzer
• Version Model Number: iFlash 9000-A
• Catalog Number: FG0076
• Company DUNS: 420735989
• Company Name: Shenzhen YHLO Biotech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06925912715221 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2022-11-03
• Device Publish Date: 2022-10-26

On-Brand Devices [iFlash 9000 CLIA Analyzer]

• 06925912718154: Type A, autoload
• 06925912715221: Type A, Standard