Identity
- Trade Name
- OHC COVID-19/ Flu Antigen Test Pro FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical FDA UDI
- Device Name
- 25 Test / Kit FDA UDI
- Model / Reference
- OI-01SU-CC FDA UDI
- Description
- 25 Test / Kit FDA UDI
Identifiers
- Catalog Number
- RAUCC25ENP1 FDA UDI
- Primary DI / UDI-DI
- 08809115903297 FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Influenza A/B virus antigen IVD, kit, rapid ICT, clinicalSARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical
OHC COVID-19/ Flu Antigen Test Pro by OSANG HEALTHCARE Co., Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- OSANG HEALTHCARE Co., Ltd.
Sources (1)
- FDA UDI 57daba45-5b2c-435f-adc7-c25e24f70cc0 36 fields · synced May 29, 2026