iFlash-Androstenedione

GUDID 06925912718055

Shenzhen YHLO Biotech Co., Ltd.

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• Primary Device ID: 06925912718055
• NIH Device Record Key: 8408e2d0-da8c-4e1c-aaf6-e6cb6c76cbb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFlash-Androstenedione
• Version Model Number: C86062
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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	06925912718055 [Primary]

FDA Product Code

• CIZ: Radioimmunoassay, Androstenedione

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