Smilereader ovulation test kit

GUDID 06938444981002

The convenience kit consisting of 5 Ovulation Test device and 1 Pregnancy Test devices.

Runbio Biotech Co., Ltd.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 06938444981002
• NIH Device Record Key: fbc9176e-3465-4d70-8778-4ab86d38b84c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smilereader ovulation test kit
• Version Model Number: 81002
• Company DUNS: 545868502
• Company Name: Runbio 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	06938444981002 [Primary]

FDA Product Code

• OIE: Urine Collection Kit (Excludes Hiv Testing)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-08-15

On-Brand Devices [Smilereader ovulation test kit]

• 06938444981019: The convenience kit consisting of 15 ovulation test devices and 5 pregnancy test devices.
• 06938444981002: The convenience kit consisting of 5 Ovulation Test device and 1 Pregnancy Test devices.