DAVID RH-LH-B

GUDID 06938444980036

The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) i

Runbio Biotech Co., Ltd.

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• Primary Device ID: 06938444980036
• NIH Device Record Key: 643edb59-547a-41d6-a865-a5b5f2cd453b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAVID
• Version Model Number: RH-LH-B
• Catalog Number: RH-LH-B
• 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

Customer Support Contacts

• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com
• Phone: 310-5320009
• Email: TestAgents.LLC@gmail.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938444980036 [Primary]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-05-11

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