UNION Immune Analyzer U6103

GUDID 06925912711117

Shenzhen YHLO Biotech Co., Ltd.

Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: 06925912711117
• NIH Device Record Key: 9ae006ff-cbc1-448e-819e-b11fa72bd409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNION Immune Analyzer
• Version Model Number: UNION-C
• Catalog Number: U6103
• 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	06925912711117 [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

Devices Manufactured by Shenzhen YHLO Biotech Co., Ltd.

• 06925912718703 - iFlash-HCG: 2024-02-07
• 06925912718833 - iFlash-Anti-Beta2-Glycoprotein I: 2024-01-08 "Beta" is identical to the second letter of Greek alphabet. Because GUDID system couldn't recognize this letter, it is replaced
• 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