OHC COVID-19 Antigen Self Test FBE00625

GUDID 08809115904645

1 Test Kit / Box

OSANG HEALTHCARE Co., Ltd.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 08809115904645
• NIH Device Record Key: 06e694be-3ed7-46cf-bc96-10ba1acdbe98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OHC COVID-19 Antigen Self Test
• Version Model Number: OI-01SA-SH
• Catalog Number: FBE00625
• Company DUNS: 688195374
• Company Name: OSANG HEALTHCARE 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

Customer Support Contacts

• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809115904645 [Primary]

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: 2022-06-29
• Device Publish Date: 2022-06-21

On-Brand Devices [OHC COVID-19 Antigen Self Test]

• 08809115904645: 1 Test Kit / Box
• 08809115904621: 2 Test Kit / Box
• 08809115904614: 4 Test Kit / Box
• 08809115904607: 5 Test Kit / Box
• 08809115904591: 25 Test Kit / Box