Surearly™ Digital Ovulation Test HLHM020E

GUDID 08809408860863

Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.

Sugentech Inc._Osong Branch

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 08809408860863
• NIH Device Record Key: f1f8fe1c-cead-41ad-bd77-b50c9efa25a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surearly™ Digital Ovulation Test
• Version Model Number: SU-DR01-LH
• Catalog Number: HLHM020E
• Company DUNS: 694860936
• Company Name: Sugentech Inc._Osong Branch
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com
• Phone: 1-800-526-0943
• Email: info@sugentech.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809408860245 [Primary]
GS1	08809408860863 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-03
• Device Publish Date: 2020-10-26

On-Brand Devices [Surearly™ Digital Ovulation Test]

• 08809408860863: Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determ
• 08809408860870: Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determ