ZiQ

GUDID 06938444982719

ZiQ Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. It contains 12 test cassettes each in one small box.

Equinox Biotech Co., Ltd.

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 06938444982719
• NIH Device Record Key: b8dc69ec-07b6-4a2f-8960-04f623c1d43a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZiQ
• Version Model Number: 8271
• Company DUNS: 545868502
• Company Name: Equinox Biotech Co., Ltd.
• Device Count: 12
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938444982719 [Unit of Use]
GS1	16938444982716 [Primary]

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: 2025-03-03
• Device Publish Date: 2025-02-21

Devices Manufactured by Equinox Biotech Co., Ltd.

• 06938444982719 - ZiQ: 2025-03-03ZiQ Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. It contains 12 test cassettes each in one small box.
• 06938444982719 - ZiQ: 2025-03-03 ZiQ Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG
• 06938444981316 - INVBIO: 2022-11-23 HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropi
• 06938444981323 - INVBIO: 2022-11-23 The convenience kit consisiting of 50 ovulation test strips 3mm and 20 pregnancy test strips 3mm.
• 06938444982238 - AFAC One Step HCG and Ovulation Urine test Kit: 2022-11-23 The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips .
• 06938444982351 - SMILEREADER Ovulation Test Kit: 2022-11-23 The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips .