| Primary Device ID | 08809115903297 |
| NIH Device Record Key | 57daba45-5b2c-435f-adc7-c25e24f70cc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OHC COVID-19/ Flu Antigen Test Pro |
| Version Model Number | OI-01SU-CC |
| Catalog Number | RAUCC25ENP1 |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com | |
| Phone | 1-844-760-0556 |
| covidhometest@osangllc.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08809115903297 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-20 |
| Device Publish Date | 2024-05-10 |
| 08809115903297 - OHC COVID-19/ Flu Antigen Test Pro | 2024-05-2025 Test / Kit |
| 08809115903297 - OHC COVID-19/ Flu Antigen Test Pro | 2024-05-20 25 Test / Kit |
| 08809115904423 - QuickFinder™ COVID-19/Flu Antigen Self Test | 2024-05-20 2 Test / Kit |
| 08809115904119 - CURO L5 Glucose test strip | 2022-10-04 Glucose test strip(25T) |
| 08809115904225 - QuickFinder COVID-19 Antigen Self Test | 2022-06-30 25 Test Kit / Box |
| 08809115904232 - QuickFinder COVID-19 Antigen Self Test | 2022-06-30 5 Test Kit / Box |
| 08809115904249 - QuickFinder COVID-19 Antigen Self Test | 2022-06-30 4 Test Kit / Box |
| 08809115904256 - QuickFinder COVID-19 Antigen Self Test | 2022-06-30 2 Test Kit / Box |
| 08809115904263 - QuickFinder COVID-19 Antigen Self Test | 2022-06-30 1 Test Kit / Box |