Early Blush Pregnancy Test (30 HCG Strips)

GUDID 06938444982184

Early Blush Pregnancy Test (30 HCG Strips) is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 30 strips in one box.

Runbio Biotech Co., Ltd.

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

• Primary Device ID: 06938444982184
• NIH Device Record Key: 592fa5ec-5ed7-4009-b149-43841cf5f859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Early Blush Pregnancy Test (30 HCG Strips)
• Version Model Number: 82184
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938444982184 [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: 2019-07-08
• Device Publish Date: 2019-06-28

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