DAVID

GUDID 06938444982269

This product is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 strips and 3 midstreams in one box.

Runbio Biotech Co., Ltd.

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

• Primary Device ID: 06938444982269
• NIH Device Record Key: dc53e7b3-0623-437f-a592-c402f64a3d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAVID
• Version Model Number: 82269
• Company DUNS: 545868502
• Company Name: Runbio Biotech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938444982269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181551

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2020-08-12
• Device Publish Date: 2020-08-04

On-Brand Devices [DAVID]

• 06938444980036: The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qua
• 06938444982283: The convenience kit is consisiting of 8 ovulation test midstrems and 2 pregnancy test midstrems.
• 06938444982276: The convenience kit is consisiting of 50 ovulation test strips and 25 pregnancy test strips .
• 06938444982269: This product is intended for the qualitative determination of human chorionic gonadotropin (hCG)
• 06938444982412: The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips .
• 06938444982610: DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotrop
• 06938444982603: DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and 30 pregnancy tes
• 06938444982641: DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy te