I-UNICELL Incubator I6101

GUDID 06925912711049

Shenzhen YHLO Biotech Co., Ltd.

Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD Microplate/tube/assay card incubator IVD

• Primary Device ID: 06925912711049
• NIH Device Record Key: ae70d583-ab28-461d-bf89-bcf912e75afd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-UNICELL Incubator
• Version Model Number: I-UNICELL
• Catalog Number: I6101
• 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	06925912711049 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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

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• 06925912708506 - Reaction vessel: 2022-11-03 2000 pcs/box (2 bag/box, 1000 pcs/bag)
• 06925912710424 - Chemiluminescence Immunoassay Analyzer: 2022-11-03 Type A
• 06925912710462 - Chemiluminescence Immunoassay Analyzer: 2022-11-03 Type B
• 06925912710509 - Chemiluminescence Immunoassay Analyzer: 2022-11-03 Type C
• 06925912710547 - Chemiluminescence Immunoassay Analyzer: 2022-11-03 Type D
• 06925912710578 - Chemiluminescence Immunoassay Analyzer: 2022-11-03